MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
FDA 510(k) clearance K031700 · decided 2003-08-29
Clearance details
- K-number
- K031700
- Device name
- MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-06-02
- Decision date
- 2003-08-29
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with recall (Z-1919-2008) | Medtronic Perfusion Systems | 2008-07-24 |