510(k) K221032
- Device
- Vascu-Guard Vascular Repair Patch
- Applicant
- Synovis Life Technologies, Inc.
- 510(k) number
- K221032
- Product code
- PSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-19
- Date received
- 2022-04-07
- Regulation
- 870.3470
- Classification name
- Intracardiac Patch Or Pledget, Biologically Derived
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sajjad Megan
- Address
- (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W. St. Paul MN US 55114 55114
FDA Registration Numbers#
- 2183620
- 3012664855
- 3032916632
- 1416980
- 1225991
- 1063481
- 1047843
- 1450662
- 1220948
- 3005920706
- 3020856782
- 3009882464
- 9680579
- 3012102437
- 1000393132
- 3025316685
- 3015436824
- 3003418325
- 3010805634
- 1835959
Source Documents#
Other 510(k) Records For Product Code PSQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021-12-21 |
| K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | 2020-04-03 |
| K190882 | XenoSure Biologic Patch | Lemaitre Vascular | 2020-02-13 |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | 2019-11-22 |
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2019-02-14 |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | Cormatrix Cardiovascular, Inc. | 2018-10-10 |
| K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-12-04 |
| K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | 2017-11-17 |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | 2017-04-28 |
Legacy Summary#
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FDA Review#
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