CARDIOPULMONARY BYPASS
FDA 510(k) clearance K810820 · decided 1981-04-03
Clearance details
- K-number
- K810820
- Device name
- CARDIOPULMONARY BYPASS
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-24
- Decision date
- 1981-04-03
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 recall (Z-1796-2024) | Medtronic Perfusion Systems | 2024-05-10 |
| Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DL recall (Z-1799-2024) | Medtronic Perfusion Systems | 2024-05-10 |
| Medtronic DLP Vessel Cannula, Model Number REF 30000 recall (Z-1316-2024) | Medtronic Perfusion Systems | 2024-03-19 |