Panels › Cardiovascular › Product code PSQ · Class 2
Intracardiac Patch Or Pledget, Biologically Derived
Regulation 870.3470
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Admedus Regen Pty, Ltd. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Cryolife, Inc. | 2 | 0 |
| Synovis Life Technologies, Inc. | 2 | 0 |
| Acell, Inc. | 1 | 0 |
| Cormatrix Cardiovascular, Inc. | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| Helios Cardio, Inc. | 1 | 0 |
| Lemaitre Vascular | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Vascu-Guard Peripheral Vascular Patch (US), Product Codes:
a) VG0108: 0.8 X 8 CM US, TS;
b) VG0110: 1 X 10 CM US, TS;
c) VG0106: 1 X 6 CM US, TS;
d) VG0209: 2 X 9 CM US, TS Open, Classified |
PSQ | K221032 |
| Jan 5, 2024 | Baxter Healthcare Corporation Peri-Guard Repair Patch, Product Codes:
a) PG1016 : 10 X 16 CMUS, TS
b) PG1225: 12 X 25 CMUS, TS
c) PG0404: 4 X 4 CMUS, TS
d) PG0608: 6 X 8CMUS, TS
e) PG0814: 8 X 14 CMUS, TS Open, Classified |
PSQ | K221029 |
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