MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
FDA 510(k) clearance K924642 · decided 1993-03-26
Clearance details
- K-number
- K924642
- Device name
- MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
- Applicant
- Medtronic Bio-Medicus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-14
- Decision date
- 1993-03-26
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numb recall (Z-1928-2008) | Medtronic Perfusion Systems | 2008-07-24 |