Cardiovascular Repair Patch
FDA 510(k) K905073 · Impra, Inc.
510(k) numberK905073
Submission
- Device name
- Cardiovascular Repair Patch
- Applicant
- Impra, Inc.
Tempe, AZ, US - Received
- November 9, 1990
- Decision date
- December 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981079 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDSY · Traditional | 05/07/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
Questions and answers
When was Cardiovascular Repair Patch cleared by the FDA?
Cardiovascular Repair Patch (K905073) received a 510(k) decision of Substantially Equivalent on December 20, 1991, 406 days after the submission was received.
What is the product code of K905073?
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.