Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

Q: Who is the manufacturer of Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)?

Arrow International, LLC (A subsidiary of Teleflex, Inc.) filed the 510(k) submission for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (K242281).

Q: What is the FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)?

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

Q: Who can help prepare an FDA 510(k) submission like Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)?

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.

K242281 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · FOZ · Dec 20, 2024 · General Hospital

Device Facts

Record ID	K242281
Device Name	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
Applicant	Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Product Code	FOZ · General Hospital
Decision Date	Dec 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use.

Device Story

Sterile, single-use peripheral intravascular catheter system; provides access to peripheral vascular system for venous or arterial use. System includes insertion platform (handle, echogenic needle, guide wire, slider advancer) and catheter. Clinician gains vascular access via needle, advances guide wire, then advances catheter; needle safety mechanism minimizes sharps injury risk. Catheter supports high-pressure contrast injections (up to 325 psi) and arterial pressure monitoring. Used in hospitals and clinics by healthcare professionals. Benefits include reliable vascular access for fluid/blood management and reduced sharps injury risk. Output is physical access to the vascular system for clinical monitoring or therapy.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included surface integrity, mechanical strength (tensile, kink, burst), flow rates, pressure injection performance, needle safety, and biocompatibility per ISO 10993-1.

Technological Characteristics

Materials: Polypropylene (guard), Polycarbonate (handle, advancer, needle supports), ABS (slider), Stainless Steel (needle, needle safety), Nitinol (guide wire), Acetal (clamp), Polyurethane (juncture hub, extension line, luer hub, catheter body). Catheter body features Quadraflex polyurethane with MDX silicone coating. MR Safe. Ethylene oxide sterilization. Passive needle safety mechanism. 20G and 22G configurations.

Indications for Use

Indicated for patients requiring peripheral vascular access for short-term (less than 30 days) venous use (blood sampling, fluid administration, high-pressure contrast injection up to 325 psi) or arterial use (blood pressure monitoring, blood sampling). Suitable for any patient population based on anatomical adequacy and procedure appropriateness. Used in hospitals, clinics, and advanced clinical facilities.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513)

Related Devices

K151513 — Arrow Endurance Extended Dwell Peripheral Catheter System · Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) · Jul 8, 2015
K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 23, 2015
K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Feb 24, 2017
K202060 — Disposable IV catheter · Shinva Ande Healthcare Apparatus Co., Ltd. · Jul 23, 2021
K160235 — ViaValve Safety I.V. Catheter · Smiths Medical Asd, Inc. · Jun 30, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. #### December 20, 2024 Arrow International, LLC (A Subsidiary of Teleflex, Inc.) Kim Pennington Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560 Re: K242281 Trade/Device Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 22, 2024 Received: November 22, 2024 Dear Kim Pennington: 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. 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). {1}------------------------------------------------ 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 Rue"). 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 medical devices and radiation-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-regulatoryassistance/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). {2}------------------------------------------------ Sincerely, Porsche Bennett Porsche Bennett, For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K242281 Device Name Arrow™ Endurance™ Extended Dwell Peripheral Catheter System #### Indications for Use (Describe) The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling. The safety feature is intended to minimize the risk of sharps injuries. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities. Type of Use (Select one or both, as applicable) | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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- K242281 #### 1. Submitter Information | Name: | Arrow International, LLC (a subsidiary of Teleflex Inc.) | |-------------------|----------------------------------------------------------| | Address: | 3015 Carrington Mill Blvd Morrisville, NC 27560 | | Telephone Number: | (610) 451-3095 | | Contact Person: | Kim Pennington Sr. Regulatory Affairs Specialist | | Email: | kim.pennington@teleflex.com | | Date Prepared: | December 20, 2024 | #### 2. Device Name Device Trade Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200) #### 3. Predicate Device K163513: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200) ## 4. Device Description The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance" Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15"). ## 5. Intended Use The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use. {5}------------------------------------------------ ## 6. Indications for Use The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling. The safety feature is intended to minimize the risk of sharps injuries. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities. # 7. Technological Characteristics The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is substantially equivalent to the predicate Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) in terms of indications for use, intended use, design, functional performance and materials of construction. | Features | Subject Device: | Predicate Device | Assessment of Device Differences | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | | | Intended Use | The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use. | The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use. | Same | | Indication for Use | The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short- | The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short- | Different The subject device IFU separates | | Features | Subject Device: | Predicate Device | Assessment of Device Differences | | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | | | | patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, administer blood and blood products, and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling. The safety feature is intended to minimize the risk of sharps injuries. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities. | term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries. | peripheral vascular system into Vascular and Arterial usage and added the patient population and usage environment. While there is a difference in granularity, the intended use and indications for use of the subject device is similar. The difference does not raise new or different questions of safety and effectiveness. | | Single Use | Yes | Yes | Same | | Duration of Use | Less than 30 days | Less than 30 days | Same | | Insertion | Gain vascular access with needle, | Gain vascular access with needle, | Same | | Features | Subject Device: | Predicate Device | Assessment of Device Differences | | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | | | Technique | advance guide wire, advance catheter, remove needle and guidewire, deploy needle safety | advance guide wire, advance catheter, remove needle and guidewire, deploy needle safety | | | Principle of Operation | The catheter is a closed fluid path system that consists of an insertion platform and a catheter. | The catheter is a closed fluid path system that consists of an insertion platform and a catheter. | Same | | Shelf Life | 6 months | 2 years | Different Based on business needs and does not affect substantial equivalence. Bench testing and labeling support that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | MR Safety | MR Safe (catheter) | MR Safe (catheter) | Same | | Device Design Feature | | | | | Device Components | Includes Guard, Handle, Advancer, Slider, Needle Supports, Needle Safety, Extension Line Clamp, Needle, Guide Wire, Juncture Hub, Catheter with Extension Line | Includes Guard, Handle, Advancer, Slider, Needle Supports, Needle Safety, Extension Line Clamp, Needle, Guide Wire, Juncture Hub, Catheter with Extension Line | Same | | Device Materials | Guard - Polypropylene Handle - Polycarbonate Advancer – Polycarbonate Slider -ABS Needle Supports - Polycarbonate Needle Safety - Stainless Steel Extension Line Clamp - Acetal | Guard - Polypropylene Handle - Polycarbonate Advancer – Polycarbonate Slider -ABS Needle Supports - Polycarbonate Needle Safety - Stainless Steel Extension Line Clamp - Acetal | Different The catheter body and coating and Extension Line Clamp materials are different. Biocompatibility and bench top testing demonstrate the difference does not raise new or different questions of safety and effectiveness. | | Features | Subject Device: | Predicate Device | Assessment of Device Differences | | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | | | | Needle – Stainless Steel Guide Wire - Nitinol Juncture Hub – Polyurethane Extension Line - Polyurethane Luer Hub - Polyurethane Catheter Body– Quadraflex Polyurethane with Silicone Coating | Needle - Stainless Steel Guide Wire - Nitinol Juncture Hub – Polyurethane Extension Line - Polyurethane Luer Hub - Polyurethane Catheter Body - Tecoflex Polyurethane | | | Catheter Design Configuration | The insertion platform consists of an ergonomically designed polycarbonate handle, an integral echogenic needle with openings to enhance flashback visibility to confirm placement in the vessel, a passive needle safety mechanism, a needle support to aid in insertion, and a guide wire with a slider advancer. | The insertion platform consists of an ergonomically designed polycarbonate handle, an integral echogenic needle with openings to enhance flashback visibility to confirm placement in the vessel, a passive needle safety mechanism, a needle support to aid in insertion, and a guide wire with a slider advancer. | Same | | Catheter Body OD | 20 Ga, 22 Ga | 18 Ga, 20 Ga, 22 Ga | Different The subject device does not include 18Ga | | Catheter Body ID | 0.032" (20 Ga) 0.027" (22 Ga) | 0.039" (18 Ga) 0.032" (20 Ga) 0.027" (22 Ga) | Different The subject device does not include 18Ga | | Catheter Usable Length | 6 cm (2.36") 8 cm (3.15") | 6 cm (2.36") 8 cm (3.15") | Same | | Needle Safety Feature | Yes | Yes | Same | | Features | Subject Device: | Predicate Device | Assessment of Device Differences | | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | | | Blood Safety Feature | Bloodless (seal and extension lines) | Bloodless (seal and extension lines) | Same | | Pressure Injection Limits | 325 psi | 325 psi | Same | | Sidearm Clamp | Pinch | Slide | Different A different clamp has no impact on substantial equivalence. Bench testing supports that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | Juncture Hub Advancer | Half Circle Suture Wing Posts Removed Hub Nose Clips | Round Suture Wing Posts Hub Nose Clips | Different Juncture hub advancer design changes have no impact on substantial equivalence. Bench testing supports that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | Handle | Lower needle support No Catheter Release Tab | No Lower Needle Support Catheter Release Tab | Different Handle design changes have no impact on substantial equivalence. Bench testing supports that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | Catheter Body Material | Quadraflex Polyurethane | Tecoflex Polyurethane | Different The difference in the catheter body material has no impact on the use or functionality of the subject Endurance™ Catheter per its intended use as demonstrated by bench and biocompatibility testing, supporting that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | Coating | MDX Silicone | None | Different | | Features | Subject Device: | Predicate Device | Assessment of Device Differences | | | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) | The addition of a coating has no impact on the use or functionality of the subject Endurance™ Catheter per its intended per its intended use as demonstrated by bench and biocompatibility testing, supporting that there are no new safety or effectiveness concerns. See Nonclinical Testing. | | Sterilization | | | | | Sterile | Yes…