FOX PLUS PTA CATHETER
FDA 510(k) clearance K040954 · decided 2004-05-11
Clearance details
- K-number
- K040954
- Device name
- FOX PLUS PTA CATHETER
- Applicant
- Abbott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-13
- Decision date
- 2004-05-11
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AUSAB; Alinity i Anti-HBs (P050051/S061) | Abbott Laboratories, Inc. | 2025-04-03 |
| ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S060) | Abbott Laboratories, Inc. | 2024-05-23 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S059) | Abbott Laboratories, Inc. | 2024-03-22 |
| ARCHITECT AUSAB (P050051/S050) | Abbott Laboratories, Inc. | 2024-01-19 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S058) | Abbott Laboratories, Inc. | 2023-12-14 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S057) | Abbott Laboratories, Inc. | 2023-12-07 |
| Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent (P050051/S056) | Abbott Laboratories, Inc. | 2023-11-06 |
| Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K (P050051/S055) | Abbott Laboratories, Inc. | 2023-11-03 |