FLO-RESTER
FDA 510(k) clearance K883696 · decided 1988-11-30
Clearance details
- K-number
- K883696
- Device name
- FLO-RESTER
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-30
- Decision date
- 1988-11-30
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes recall (Z-0656-2024) | Baxter Healthcare Corporation | 2024-01-05 |