INTRACARDIAC SUMP 12010
FDA 510(k) clearance K850385 · decided 1985-04-29
Clearance details
- K-number
- K850385
- Device name
- INTRACARDIAC SUMP 12010
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-01
- Decision date
- 1985-04-29
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b recall (Z-1797-2024) | Medtronic Perfusion Systems | 2024-05-10 |
| DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intende recall (Z-0609-2009) | Medtronic Cardiovascular Revascularization & Surgical Therap | 2009-01-26 |