CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
FDA 510(k) clearance K132524 · decided 2014-06-13
Clearance details
- K-number
- K132524
- Device name
- CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2013-08-12
- Decision date
- 2014-06-13
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator (861304) (P180028/S019) | Philips Medical Systems | 2026-05-21 |
| HeartStart FRx Defibrillator (P180028/S018) | Philips Medical Systems | 2026-02-02 |
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |