SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
FDA 510(k) clearance K010737 · decided 2001-04-04
Clearance details
- K-number
- K010737
- Device name
- SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
- Applicant
- Medtronic Cardiac Surgical Products
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-04-04
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- 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 Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 788 recall (Z-0998-2014) | Medtronic Inc. Cardiac Rhythm Disease Management | 2014-02-20 |