MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
FDA 510(k) clearance K033264 · decided 2003-10-31
Clearance details
- K-number
- K033264
- Device name
- MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-10-09
- Decision date
- 2003-10-31
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascul recall (Z-1924-2008) | Medtronic Perfusion Systems | 2008-07-24 |