Vascu-Guard Vascular Repair Patch
FDA 510(k) K221032 · Synovis Life Technologies, Inc.
510(k) numberK221032
Submission
- Device name
- Vascu-Guard Vascular Repair Patch
- Applicant
- Synovis Life Technologies, Inc.
St. Paul, MN, US - Received
- April 7, 2022
- Decision date
- October 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSQ – Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Other 510(k)s with product code PSQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional | Helios Cardio, Inc. | 12/21/2021SE |
| K200566 | ADAPT TissuePSQ · Special | Admedus Regen Pty, Ltd. | 04/03/2020SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | Lemaitre Vascular | 02/13/2020SE |
| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | Acell, Inc. | 11/22/2019SE |
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | Cryolife, Inc. | 02/14/2019SE |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…PSQ · Traditional | Cormatrix Cardiovascular, Inc. | 10/10/2018SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | Cryolife, Inc. | 12/04/2017SE |
| K172660 | Duravess bovine pericardial vascular patchPSQ · Traditional | Edwards Lifesciences, LLC | 11/17/2017SE |
| K170951 | CardioCel 3DPSQ · Special | Admedus Regen Pty, Ltd. | 04/28/2017SE |
More from Admedus Regen Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | 04/07/2023SE |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional | 10/19/2022SE |
| K143589 | GEM Flow COUPLER Device and SystemMVR · Special | 01/16/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | 11/25/2014SE |
| K142309 | GEM Flow COUPLER Device and SystemMVR · Special | 09/16/2014SE |
| K132727 | Gem Flow Coupler Device and SystemMVR · Special | 10/22/2013SE |
| K130896 | Vascular Probe, Vascular Probe EsDWP · Traditional | 04/24/2013SE |
Questions and answers
When was Vascu-Guard Vascular Repair Patch cleared by the FDA?
Vascu-Guard Vascular Repair Patch (K221032) received a 510(k) decision of Substantially Equivalent on October 19, 2022, 195 days after the submission was received.
What is the product code of K221032?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.