Who is the manufacturer of 8F FlowGate2 Balloon Guide Catheter?

Concentric Medical filed the 510(k) submission for 8F FlowGate2 Balloon Guide Catheter (K153729).

What is the FDA product code for 8F FlowGate2 Balloon Guide Catheter?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 8F FlowGate2 Balloon Guide Catheter?

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

What are the predicate devices for 8F FlowGate2 Balloon Guide Catheter?

Modified FlowGate™ Balloon Guide Catheter (K131492); Concentric Balloon Guide Catheter (K122581).

Who can help prepare an FDA 510(k) submission like 8F FlowGate2 Balloon Guide Catheter?

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.

8F FlowGate2 Balloon Guide Catheter

K153729 · Concentric Medical · DQY · Jan 27, 2016 · Cardiovascular

Device Facts

Record ID	K153729
Device Name	8F FlowGate2 Balloon Guide Catheter
Applicant	Concentric Medical
Product Code	DQY · Cardiovascular
Decision Date	Jan 27, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

Flow Gate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Device Story

8F FlowGate2™ Balloon Guide Catheter; coaxial-lumen, braid-reinforced, variable stiffness catheter. Used in peripheral and neurovascular systems to facilitate insertion/guidance of intravascular catheters; balloon provides temporary vascular occlusion during angiographic procedures; serves as conduit for retrieval devices. Operated by physicians in clinical settings. Features radiopaque distal marker for visualization; bifurcated luer hub for flushing, inflation, aspiration. Packaged with accessories: dilator, rotating hemostasis valve, Tuohy Borst valve with sideport, peel-away sheaths, luer-activated valve, extension tubing. Output is physical guidance and vascular access; enables clinical decision-making by providing stable access for interventional tools. Benefits patient by facilitating minimally invasive neuro/peripheral procedures.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing included simulated use, kink resistance, tip flexibility, torque transmission, high-pressure leak, and accessory compatibility testing. All tests met established acceptance criteria.

Technological Characteristics

Coaxial-lumen, braid-reinforced (304V stainless steel), variable stiffness catheter. Materials: Pebax (various grades), Polyamide, NuSil silicone elastomer, PTFE liner, Platinum/Iridium marker band. 8F shaft OD. Sterilized via 100% EtO per ISO 11135:2007. Biocompatibility per EN ISO 10993-1.

Indications for Use

Indicated for patients undergoing percutaneous interventional procedures in peripheral and neurovascular systems requiring intravascular catheter guidance and temporary vascular occlusion.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Modified FlowGate™ Balloon Guide Catheter (K131492)
Concentric Balloon Guide Catheter (K122581)

Related Devices

K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER · Concentric Medical, Inc. · Oct 3, 2013
K231629 — 091 Balloon Guide Catheter · Eosolutions, Corp. · Oct 31, 2023
K203840 — BOSS 8F Balloon Guide Catheter · Marblehead Medical, LLC · Jan 28, 2021
K220331 — 091 Balloon Guide Catheter · Inneuroco, Inc. · Jul 29, 2022
K190749 — 087 Balloon Guide Catheter System · Q'Apel · Jul 15, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 27,2016 Concentric Medical, Inc. Mr. Shazia Hakim Senior Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, California 94041 Re: K153729 Trade/Device Name: 8F FlowGate Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 22, 2015 Received: December 28, 2015 Dear Mr. Hakim: 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 (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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # William J. Heetderks -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153729 Device Name 8F FlowGate Balloon Guide Catheter #### Indications for Use (Describe) Flow Gate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. Type of Use (Select one or both, as applicable) | ☑ 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." {3}------------------------------------------------ # 510(k) Summary | Device Trade Name: | 8F FlowGate2™ Balloon Guide Catheter | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 Class II | | Product Code: | DQY | | Submitter: | Concentric Medical, Inc. 301 E. Evelyn Avenue Mountain View, CA 94041 Tel 510 - 413-2636 Fax 510 - 413-2588 Facility Registration #2954917 | | Contact: | Shazia Hakim Senior Regulatory Affairs Specialist | Date Prepared: December 22, 2015 ### Predicate Device: | Primary Predicate Device | | |-----------------------------------------------------|----------------------------------------------| | K131492 (clearance granted October 3, 2013) | Modified FlowGate™ Balloon Guide Catheter | | Reference Predicate Device | | | K122581 (clearance granted November 21, 2012) | Concentric Balloon Guide Catheter | {4}------------------------------------------------ ### Device Description Like the predicate device, the 8F FlowGate2™ Balloon Guide Catheter is a coaxial- lumen, braidreinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. #### Accessories The 8F FlowGate2™ Balloon Guide Catheter is packaged with a Dilator, Rotating Hemostasis Valve, Tuohy Borst Valve with Sideport, Peel Away Sheaths, Luer-Activated Valve, and Extension tubing. #### Indications for Use The Indications for Use are the same as the predicate devices and are as follows: FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. ### Technological Characteristics and Product Feature Comparison The subject device, 8F FlowGate2™ Balloon Guide Catheter is substantially equivalent to the predicate devices in terms of: - indications for use - fundamental scientific technology - fundamental design - materials and processes for packaging and sterilization of devices A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below. {5}------------------------------------------------ | Product Feature Comparison of Subject Device with Predicate Devices (K122581, K131492) | | | | | |----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Indications for Use | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. | Same except for product name as “FlowGate Balloon Guide Catheter” | Same as predicate device (K131492) | Not applicable | | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Device Description | The Concentric Balloon Guide Catheters are coaxial-lumen, braid- reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. | Same except for product name as "FlowGate Balloon Guide Catheter" | Same as predicate device (K131492) | Not applicable | | Target Population | Patients undergoing percutaneous interventional procedures | Same | Same | Not applicable | | Anatomical Sites | Peripheral and neuro vasculature | Same | Same | Not applicable | | Regulatory Status | | | | | | Regulation Number | 21CFR 870.1250 | Same | Same | Not applicable | | Regulation Name | Percutaneous Catheter | Same | Same | Not applicable | | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Regulatory Class | II | Same | Same | Not applicable | | Product Code | DQY | Same | Same | Not applicable | | Materials | | | | | | Outer Jacket- Proximal Shaft | Purple Pebax® 7233 Barium sulfate | Same | Same | Not applicable | | Outer Jacket- Distal Shaft | Blue Pebax 6333 Barium sulfate | Same | Same | Not applicable | | Inner Jacket- Proximal Shaft | White Polyamide Blend Barium sulfate | Same | Same | Not applicable | | Inner Jacket - Proximal Transition | Natural Pebax 7233 Barium sulfate | Same | Same | Not applicable | | Inner Jacket - Proximal Mid Shaft | Natural Pebax 5533, Barium sulfate | Same | Same | Not applicable | | Inner Jacket - Distal Mid Shaft | Natural Pebax 4033 | Same | Same | Not applicable | | Inner Jacket - Distal Shaft | White Pebax 2533, Barium sulfate | Same | Same | Not applicable | | Distal Tip | White Pebax 2533, Barium sulfate | White Pebax 3533 White Pebax 2533 Barium sulfate | Same as predicate device (K131492) | Not applicable | | Balloon Material | NuSil MED 4035 silicone elastomer | NuSil MED 4025 silicone elastomer | Same as predicate device (K131492) | Not applicable | | Balloon Bond Adhesive | Loctite 4011 Cyanoacrylate Loctite 3974 UV Adhesive | Same | Same | Not applicable | | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Braid | 304V Stainless Steel | Same | Same | Not applicable | | Braid distal end securement | Loctite UV Adhesive | Loctite 4014 Cyanoacrylate | Same as predicate device (K131492) | Not applicable | | Liner | Etched PTFE | Same | Same | Not applicable | | Marker Band | 90% Platinum/10% Iridium | Same | Same | Not applicable | | Luer Hub Adhesive | Loctite 3321 UV Adhesive | Same | Same | Not applicable | | 2-Arm Luer Hub | Polyurethane | Same | Same | Not applicable | | Strain Relief | White Pebax 4033 White Polyolefin | White Pebax 4033 White Polyolefin | Same as predicate device (K131492) | Not applicable | | Labeled Shaft Outer Diameter | 8F (2.7mm) | Same | Same | Not applicable | | Labeled Shaft Inner Diameter | 6.4F (0.084 inch /2.1 mm) | Same | Same | Not applicable | | Maximum outer diameter along effective length | 0.108 inch | Same | Same | Not applicable | | Effective Lengths | 100 cm and 90 cm | 95 cm and 85 cm | Same as predicate device (K131492) | Not applicable | | Radiopaque Marker Location from Distal Tip | 2 mm | 0.75 mm | Same as predicate device (K131492) | Not applicable | | Radiopaque Marker Length | 0.020 inch | Same | Same | Not applicable | | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Accessory Devices Provided | Dilator (1) Rotating Hemostasis Valve (1) Tuohy Borst Valve with sideport (1) Peel Away Sheaths (2) Luer-Activated Valve (1) | Same as predicate device, with addition of Extension Tubing (1) | Same as predicate device, K131492 except for modified Dilator tip shape and Tuohy Borst Valve with Sideport with smaller ID | The 6F Dilator and Tuohy Borst Valve with Sideport have been modified to meet user preferences. Bench testing has demonstrated that the compatibility of modified 6F Dilator and Tuohy Borst Valve with Sideport with the subject device does not affect the safety and effectiveness of the device. | | Tuohy Borst Valve with Sideiport material | ABS body polypropylene cap PVC tubing polycarbonate luer silicone seal LDPE washer/ring | Same | Same as predicate device, K131492 except for Polycarbonate body polycarbonate сар PVC tubing polycarbonate luer silicone seal PTFE washer/ring | The Tuohy Borst Valve with Sideport has been modified to meet user preferences. Bench testing has demonstrated that the compatibility of modified Tuohy Borst Valve with Sideport with the subject device does not affect the safety and effectiveness of the device. | | Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) | | Dilator Shaft material | Blue Pebax Barium sulfate Bismuth subcarbonate (at tip only) Stainless Steel braid wire | Same | Same | Not applicable | | Dilator Hub material | White Polycarbonate | Same | Same | Not applicable | | Dilator Strain Relief Sleeve material | Green Pebax | Same | Same | Not applicable | | Dilator adhesive materials | Cyanoacrylate | Same | Same | Not app…