Surgisis Peripheral Vascular Patch
FDA 510(k) K001785 · Cook Biotech, Inc.
510(k) numberK001785
Submission
- Device name
- Surgisis Peripheral Vascular Patch
- Applicant
- Cook Biotech, Inc.
West Lafayette, IN, US - Received
- June 13, 2000
- Decision date
- December 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240775 | PeriBeam® Pericardial MembraneDXZ · Traditional | Tamabio | 04/18/2025SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | Vascutek, Ltd. | 07/08/2020SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | Cryolife, Inc. | 03/09/2017SE |
| K162579 | VascuCelDXZ · Special | Admedus Regen Pty, Ltd. | 10/14/2016SE |
| K152127 | CorMatrix TykeDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 02/04/2016SE |
| K151865 | PremiPatch PTFE PledgetDXZ · Traditional | Aesculap, Inc. | 10/27/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 11/25/2014SE |
| K140789 | Cormatrix Ecm for Vascular RepairDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 07/15/2014SE |
| K130872 | CardiocelDXZ · Traditional | Celxcel Pty, Ltd. | 01/30/2014SE |
More from Celxcel Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | 05/24/2024SE |
| K201000 | Biodesign Staple Line ReinforcementFTM · Traditional | 07/13/2020SE |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional | 12/27/2019SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | 03/13/2018SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | 07/10/2017SE |
| K170016 | Biodesign Fistula PlugFTM · Traditional | 06/21/2017SE |
| K170945 | Biodesign Staple Line ReinforcementOXE · Special | 04/28/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | 10/31/2016SE |
| K160136 | Flowable Wound MatrixKGN · Traditional | 09/28/2016SE |
Questions and answers
When was Surgisis Peripheral Vascular Patch cleared by the FDA?
Surgisis Peripheral Vascular Patch (K001785) received a 510(k) decision of Substantially Equivalent on December 27, 2000, 197 days after the submission was received.
What is the product code of K001785?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.