Gore Flow Reversal System Model GFRS073
FDA 510(k) K123156 · W. L. Gore & Associates, Inc.
Submission
- Device name
- Gore Flow Reversal System Model GFRS073
- Applicant
- W. L. Gore & Associates, Inc.
Phonix, AZ, US - Received
- October 9, 2012
- Decision date
- December 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic…
Other 510(k)s with product code NTE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | MicroVention, Inc. | 04/27/2023SE |
| K230402 | ENROUTE® Transcarotid Neuroprotection SystemNTE · Special | Silk Road Medical | 04/11/2023SE |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | Cordis Corporation | 04/06/2022SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | Cardiovascular Systems, Inc. | 03/03/2021SE |
| K200198 | WirionNTE · Traditional | Cardiovascular Systems, Inc. | 03/18/2020SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | Abbott Vascular | 07/25/2019SE |
| K180023 | WirionNTE · Traditional | Gardia Medical , Ltd. | 03/21/2018SE |
| K153485 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 03/10/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | Abbott Vascular | 11/20/2015SE |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
More from Gardia Medical
| 510(k) | Device | Decision |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
Questions and answers
When was Gore Flow Reversal System Model GFRS073 cleared by the FDA?
Gore Flow Reversal System Model GFRS073 (K123156) received a 510(k) decision of Substantially Equivalent on December 13, 2012, 65 days after the submission was received.
What is the product code of K123156?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.