CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
FDA 510(k) clearance K050172 · decided 2005-03-31
Clearance details
- K-number
- K050172
- Device name
- CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
- Applicant
- Cardiomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-26
- Decision date
- 2005-03-31
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DRN
- Device class
- 2
- Regulation number
- 870.5225
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Seri recall (Z-1582-2009) | Cardiomedics Incorporated | 2009-07-07 |