FLO-THRU
FDA 510(k) clearance K981624 · decided 1998-08-04
Clearance details
- K-number
- K981624
- Device name
- FLO-THRU
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-07
- Decision date
- 1998-08-04
- Days to decision
- 89 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 |
|---|---|---|
| Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS1 recall (Z-1523-2024) | Baxter Healthcare Corporation | 2024-04-12 |
| Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b recall (Z-0663-2024) | Baxter Healthcare Corporation | 2024-01-05 |
| Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Us recall (Z-1019-2022) | Baxter Healthcare Corporation | 2022-04-29 |