Who is the manufacturer of QuikClot Control+ Hemostatic Device?

Teleflex Medical filed the 510(k) submission for QuikClot Control+ Hemostatic Device (K243553).

What is the FDA product code for QuikClot Control+ Hemostatic Device?

POD. It is classified under 21 CFR 878.4454 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for QuikClot Control+ Hemostatic Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for QuikClot Control+ Hemostatic Device?

QuikClot Control+ Hemostatic Dressing (K220971); D2 Hemostatic Dressing (K140757).

Who can help prepare an FDA 510(k) submission like QuikClot Control+ Hemostatic Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QuikClot Control+ Hemostatic Device

K243553 · Teleflex Medical · POD · Mar 18, 2025 · General, Plastic Surgery

Device Facts

Record ID	K243553
Device Name	QuikClot Control+ Hemostatic Device
Applicant	Teleflex Medical
Product Code	POD · General, Plastic Surgery
Decision Date	Mar 18, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4454
Device Class	Class 2
Attributes	Therapeutic

Intended Use

QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

Device Story

QuikClot Control+ is a sterile, X-ray detectable hemostatic dressing composed of gauze, kaolin, and calcium alginate. Used in clinical settings (OR, trauma, emergency), it is applied by healthcare professionals directly into or onto a wound. Hemostasis is achieved via kaolin-induced clotting and mechanical compression. The dressing may remain in place for up to 48 hours before removal. It is intended for use on patients with various bleeding severities, including those on anticoagulation or antiplatelet therapy, and can be used with or without cardiopulmonary bypass or blood salvage equipment. By providing rapid hemostasis, the device assists in managing surgical and traumatic bleeding, potentially reducing blood loss and improving patient outcomes in critical care scenarios.

Clinical Evidence

Retrospective observational study of 603 patient cases (404 internal, 199 external) across 74 U.S. sites. Primary endpoint: successful control of bleeding. Results: 98.7% success in internal use, 97% in external use. Safety endpoints: hematoma rates of 0.5% (internal) and 1% (external); no reports of thrombus or thromboembolism. Evidence supports safety and effectiveness for mild, moderate, severe, and life-threatening bleeding.

Technological Characteristics

Materials: Gauze substrate, kaolin (hemostatic agent), calcium alginate (binder). Form factor: Sterile dressing in various sizes. Energy source: None (mechanical/chemical). Connectivity: None. Sterilization: Gamma radiation. Biocompatibility: Compliant with ISO 10993-1 for prolonged contact.

Indications for Use

Indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding in all patient populations.

Regulatory Classification

Identification

A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must: (i) Demonstrate that the device is able to achieve hemostasis; (ii) Demonstrate that the device can be radiographically detected; and (iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation. (2) The device must be demonstrated to be biocompatible. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed: (i) In vitro clot assessment; (ii) Particulate release testing; (iii) Physical characterization, including swelling percent and particulate size; (iv) Chemical characterization; (v) Radiopacity testing; and (vi) Mechanical integrity testing, including tensile strength and tear strength. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling must include the following: (i) Instructions for use, including an instruction to remove all visible device components by irrigation; (ii) The maximum amount of time the device may be left within the body; (iii) A shelf life; (iv) A contraindication for intravascular use of the device; and (v) A warning regarding the potential for adhesion formation.

Predicate Devices

QuikClot Control+ Hemostatic Dressing (K220971)
D2 Hemostatic Dressing (K140757)

Related Devices

K200167 — QuikClot Control+ · Z-Medica, LLC · Apr 23, 2020
K220971 — QuikClot Control+ Hemostatic Dressing · Z-Medica, LLC · Dec 14, 2022
K123387 — QUIKCLOT HEMOSTATIC DRESSING · Z-Medica, LLC · Apr 12, 2013
K140757 — D2 HEMOSTANTIC DRESSING · Z-Medica, LLC · Jul 17, 2014
K181641 — QuikClot Radial · Z-Medica, LLC · Dec 24, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 18, 2025 Teleflex Medical Jane Doll Regulatory Affairs Team Lead 3015 Carrington Mill Blyd Morrisville, North Carolina 27560 Re: K243553 Trade/Device Name: QuikClot Control+ Hemostatic Device Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD. OSY Dated: February 14, 2025 Received: February 14, 2025 Dear Jane Doll: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # TEK N. LAMICHHANE -S Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243553 Device Name QuikClot Control+ Hemostatic Device Indications for Use (Describe) QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) SUMMARY (K243553) #### I. Submitter Information | Name: | Teleflex Medical | |----------|----------------------------------------------------| | Address: | 3015 Carrington Mill Blvd Morrisville, NC 27560 | | Contact Person: | Jane Doll | |-------------------|------------------------| | Telephone Number: | (919) 361-3973 | | Email: | jane.doll@teleflex.com | Date Prepared: February 21, 2025 #### II. Device Name | Name of Device: | QuikClot Control+TM Hemostatic Device | |----------------------|------------------------------------------------------| | Common Name: | Temporary, Internal Use Hemostatic Wound Dressing | | Classification Name: | Temporary, Internal Use Hemostatic (21 CFR 878.4454) | | Regulatory Class: | II | | Product Code: | POD | #### III. Predicate Device Primary Predicate: QuikClot Control+TM Hemostatic Dressing (K220971) Secondary Predicate: D2 Hemostatic Dressing (K140757) #### IV. Device Description and Mechanism of Action # Device Description QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal. # Mechanism of Action The QuikClot Control+ Hemostatic Devices are packed into or on the wound and pressure is applied. Pressure is maintained until the bleeding is controlled and may be left in place up to 48 hours. More than one QuikClot Control+ hemostatic device can be used. Hemostasis is achieved through the activity of the hemostatic agent kaolin bound to the gauze in conjunction with compression. #### V. Indications for Use QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding. #### VI. Technological Characteristics and Substantial Equivalence The Proposed Device is identical to the Primary Predicate in terms of intended use, target population, materials of construction (including hemostatic agent and binder), sizes, prescription use, patient contact time, how supplied, sterilization method, shelf-life, single use, packaging and biocompatibility. Additionally, the Proposed Device is identical in {5}------------------------------------------------ formulation, mode of operation/mechanism of action, and scientific technological characteristics. The change to the device is a modification to the indications for use. Table 1 below provides a comparison of the Proposed Device and Primary Predicate Device. | Parameter | Proposed Device (K243553) QuikClot Control+TM Hemostatic Device | Primary Predicate Device – K220971 QuikClot Control+TM Hemostatic Dressing | Comparison | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life- threatening bleeding. | QuikClot Control+ Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying Class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy. | Modification to the indications for use wording to align with the wording of the VIBe scale for mild, moderate, severe, and life- threatening, covering the full range of identifiable sites of internal bleeding. | | Intended Use | To control internal and external bleeding. To control bone surface bleeding. | To control internal and external bleeding. To control bone surface bleeding at the sternotomy access site | Minor edits for clarity. Removal of “at the sternotomy access site” to support the | | Parameter | Proposed Device (K243553) QuikClot Control+TM Hemostatic Device | Primary Predicate Device - K220971 QuikClot Control+TM Hemostatic Dressing | Comparison | | | To control suture line bleeding following cardiac surgical procedures, such as but not limited to, heart valve repairs or replacements, coronary artery bypass graft surgery (CABG), or aortic aneurysm repairs. | To control suture line bleeding following cardiac surgical procedures, such as but not limited to, heart valve repairs or replacements, coronary artery bypass graft surgery (CABG), or aortic aneurysm repairs. | proposed indications for use. | | | To control bleeding due to tears, lacerations, and abrasions to include epicardial repairs with or without sutures. | To control bleeding due to tears, lacerations, and abrasions to include epicardial repairs with or without sutures. | | | | May be used with or without the use of cardiopulmonary bypass systems. The dressing can be applied to control bleeding while the patient is 'on or off pump'. | To be used with or without the use of cardiopulmonary bypass systems. The dressing can be applied to control bleeding while the patient is 'on or off pump'. | | | | May be used with or without autotransfusion (blood salvage) equipment. | To be used with or without autotransfusion (blood salvage) equipment. | | | | May be used on patients on anticoagulation / antiplatelet medication. | To be used on patients on anticoagulation / antiplatelet medication. | | | Target Population | All patient populations needing control of bleeding. | All patient populations needing control of bleeding. | Same | | Contraindication | Do not leave QuikClot Control+ in place for more than 48 hours. | Do not leave QuikClot Control+ in place for more than 48 hours. | Same | | Parameter | Proposed Device (K243553) QuikClot Control+TM Hemostatic Device | Primary Predicate Device – K220971 QuikClot Control+TM Hemostatic Dressing | Comparison | | | QuikClot Control+ is not indicated for intraluminal vascular use. | QuikClot Control+ is not indicated for intraluminal vascular use. | | | Warnings | QuikClot Control+TM is not to be blindly inserted into a non-compressible internal wound. Adhesion formation associated with QuikClot Control+ Dressing use was noted in preclinical studies; adhesions were also observed with control materials. It is not known whether adhesions elicited by QuikClot Control+ Dressing are equivalent to those caused by control materials. QuikClot Control+ Dressing is not absorbable and must be removed from the wound prior to wound closure. Read all package insert warnings, precautions, and instructions prior to use. Failure to do so may result in severe patient injury or death. | Adhesion formation associated with QuikClot Control+ Dressing use was noted in preclinical studies; adhesions were also observed with control materials. It is not known whether adhesions elicited by QuikClot Control+ Dressing are equivalent to those caused by control materials. QuikClot Control+ Dressing is not absorbable and must be removed from the wound prior to wound closure. Warning: Read all package insert warnings, precautions, and instructions prior to use. Failure to do so may result in severe patient injury or death. Warning: Single use: Do not reuse, reprocess or re- sterilize. Reuse of device creates a | Addition of "QuikClot Control+TM is not to be blindly inserted into a non-compressible internal wound." | | Parameter | Proposed Device (K243553) QuikClot Control+TM Hemostatic Device | Primary Predicate Device – K220971 QuikClot Control+TM Hemostatic Dressing | Comparison | | | Single use: Do not reuse, reprocess or re-sterilize. Reuse of device creates a potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality. | potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality. | | | Materials of Construction | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Same | | Sizes | Various sizes including but not limited to 1" x 1", 3 ply; 4" x 2", 6 ply or 10 ply; 4" x 6", 6 ply or 10 ply; 4" x 8", 6 -10 plies; 4" x 12", 9 ply 5" x 5", 4 ply 8" x 8", 2 ply 12" x 12", 3 ply 3" x 4 yards, 1 ply 3" x 2 yards, 1 ply | Various sizes including but not limited to 1" x 1", 3 ply; 4" x 2", 6 ply or 10 ply; 4" x 6", 6 ply or 10 ply; 4" x 8", 6 -10 plies; 4" x 12", 9 ply 5" x 5", 4 ply 8" x 8", 2 ply 12" x 12", 3 ply 3" x 4 yards, 1 ply 3" x 2 yards, 1 ply | Same | | Prescription Use or Over-the- Counter (OTC) | Prescription Use | Prescription Use | Same | | Patient Contact Time | Up to 48 hours | Up to 48 hours | Same | | How Supplied | Sterile | Sterile | Same | | Sterilization Method | Gamma | Gamma | Same | | Parameter | Proposed Device (K243553) QuikClot Control+TM Hemostatic Device | Primary Predicate Device – K220971 QuikClot Control+TM Hemostatic Dressing | Comparison | | Single Use / Reusable | Single use | Single use | Same | | Packaging | Peelable foil pouch | Peelable foil pouch | Same | | Biocompatibility | Biocompatible materials used (per ISO 10993-1 prolonged contact duration). | Biocompatible materials used (per ISO 10993-1 prolonged contact duration). | Same | Table 1. Substantial Equivalence Comparison to Primary Predicate {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ The Proposed Device is substantially equivalent to the Secondary Predicate Device in that both devices are indicated for temporary control of severe bleeding and both are intended to control external bleeding. Moreover, the Proposed Device and the Secondary Predicate Device contain identical materials of construction (including hemostatic agent and binder). Accordingly, the Proposed Device and Secondary Predicate Device have identical mechanisms of action. The Proposed Device is also identical to the Secondary Predicate in terms of prescription use, how supplied, sterilization method, single use, packaging and biocompatibility. For differences in sizes, patient contact time, and shelf life, the Proposed Device is supported by testing and data from the Primary Predicate for the differences in size, and the longer patient contact time and shelf-life. Table 2 below provides a comparison of the proposed device and secondary predicate device. | Parameter | Proposed Device(K243553) QuikClot Control+TM Hemostatic Device | Secondary Predicate Device - K140757 D2 Hemostatic Dressing | Comparison | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life- threatening bleeding. | D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries. | Both are indicated for temporary, external control of severe bleeding. | | Intended Use | To control internal and external bleeding. To control bone surface bleeding. | To control external bleeding. | Both are intended to control external bleeding. | | Parameter | Proposed Device(K243553) QuikClot Control+TM Hemostatic Device | Secondary Predicate Device - K140757 D2 Hemostatic Dressing | Comparison | | | To control suture line bleeding following cardiac surgical procedures, such as but not limited to, heart valve repairs or replacements, coronary artery bypass graft surgery (CABG), or aortic aneurysm repairs. To control bleeding due to tears, lacerations, and abrasions to include epicardial repairs with or without sutures. May be used with or without the use of cardiopulmonary bypass systems. The dressing can be applied to control bleeding while the patient is 'on or off pump'. May be used with or without autotransfusion (blood salvage) equipment. May be used on patients on anticoagulation / antiplatelet medication. | | | | Target Population | All patient populations needing control of bleeding. | Battleground / Pre-Hospital / Hospital / Medical Office | The Target Population is broader and defined in line with the Primary Predicate. | | Contraindication | Do not leave QuikClot Control+ in place for more than 48 hours. | [No Contraindications stated.] | The warnings are in line with the Primary Predicate device. | | Parameter | Proposed Device(K243553) QuikClot Control+TM Hemostatic Device | Secondary Predicate Device – K140757 D2 Hemostatic Dressing | Comparison | | | QuikClot Control+ is not indicated for intraluminal vascular use. | | Vascular use appears as a Contraindication in the Proposed Device but appears as a Warning in the Secondary Predicate Device (see Warnings, 5th bullet point). | | Warnings | QuikClot Control+TM is not to be blindly inserted into a non-compressible internal wound. Adhesion formation associated with QuikClot Control+ Dressing use was noted in preclinical studies; adhesions were also observed with control materials. It is not known whether adhesions elicited by QuikClot Control+ Dressing are equivalent to those caused by control materials. QuikClot Control+ Dressing is not absorbable and must be removed from the wound prior to wound closure. Read all package insert warnings, precautions, and | Product is not absorbable and must be removed from the wound prior to wound closure. The D2 Hemostatic Dressing is not intended as a substitute for meticulous surgical technique, the use of sterile procedures, and the proper application of ligatures or other conventional procedures to control bleeding. The D2 Hemostatic Dressing must not remain in the wound for longer than 24 hours. Avoid contact with eyes. The safety and effectiveness of the D2 Hemostatic Dressing for use in | The Warnings are in line with the Primary Predicate. Addition of "QuikClot Control+TM is not to be blindly inserted into a non-compressible internal wound." | | Parameter | Proposed Device(K243553) QuikClot Control+TM Hemostatic Device | Secondary Predicate Device - K140757 D2 Hemostatic Dressing | Comparison | | | instructions prior to use. Failure to do so may result in severe patient injury or death. Single use: Do not reuse, reprocess or re-sterilize. Reuse of device creates a potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality. | neurological, ophthalmic, spinal, GI, orthopedic (bone repair), all anastomoses (including vascular) and femoral artery puncture sites have not been established. | | | Materials of Construction | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Same | | Sizes | Various sizes including but not limited to 1" x 1", 3 ply; 4" x 2", 6 ply or 10 ply; 4" x 6", 6 ply or 10 ply; 4" x 8", 6 -10 plies; 4" x 12", 9 ply 5" x 5", 4 ply 8" x 8", 2 ply 12" x 12", 3 ply 3" x 4 yards, 1 ply 3" x 2 yards, 1 ply | Various sizes ranging from 1" x 1" x 1 ply to 4" x 12ft x 2 ply…