VENOUS RETURN CANNULA W/CUFF 91039
FDA 510(k) clearance K854487 · decided 1986-02-10
Clearance details
- K-number
- K854487
- Device name
- VENOUS RETURN CANNULA W/CUFF 91039
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-08
- Decision date
- 1986-02-10
- Days to decision
- 94 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 Malleable Single Stage Venous CannulaeRx Only, Sterilized Using Ethyle recall (Z-0811-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |