PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
FDA 510(k) clearance K983162 · decided 1998-10-09
Clearance details
- K-number
- K983162
- Device name
- PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-10
- Decision date
- 1998-10-09
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC recall (Z-1377-2024) | Baxter Healthcare Corporation | 2024-03-26 |
| Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSB recall (Z-1378-2024) | Baxter Healthcare Corporation | 2024-03-26 |