VENOUS RETURN CATHETER SS-1
FDA 510(k) clearance K845045 · decided 1985-04-03
Clearance details
- K-number
- K845045
- Device name
- VENOUS RETURN CATHETER SS-1
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-28
- Decision date
- 1985-04-03
- Days to decision
- 96 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 DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model recall (Z-0808-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |
| Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterili recall (Z-0812-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |
| Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036. recall (Z-1489-04) | Medtronic Inc | 2004-09-29 |