HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
FDA 510(k) clearance K021453 · decided 2002-07-03
Clearance details
- K-number
- K021453
- Device name
- HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-05-06
- Decision date
- 2002-07-03
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The He recall (Z-0011-2013) | Philips Healthcare Inc. | 2012-10-04 |
| Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and Heart recall (Z-1135-2010) | Philips Healthcare Inc. | 2010-03-15 |
| HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The d recall (Z-1199-2009) | Philips Healthcare Inc. | 2009-05-19 |
| HeartStart XL Defibrillator/Monitor, Model: M4735A recall (Z-0062-2008) | Philips Medical Systems | 2007-10-25 |
| Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A recall (Z-1128-2007) | Philips Medical Systems | 2007-08-07 |
| Model M4735A HeartStart XL Defibrillator//Monitor recall (Z-1226-03) | Philips Medical Systems | 2003-09-11 |
| Philips HeartStart XL, Model M4735A Defibrillator/Monitor recall (Z-0343-03) | Philips Medical Systems, Inc. Cardiac & Monitoring Systems | 2002-12-18 |
PMA approvals by this applicant
| 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 |