SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
FDA 510(k) clearance K033416 · decided 2003-11-05
Clearance details
- K-number
- K033416
- Device name
- SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-10-27
- Decision date
- 2003-11-05
- Days to decision
- 9 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 Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.) recall (Z-0999-2014) | Medtronic Inc. Cardiac Rhythm Disease Management | 2014-02-20 |
| Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PV recall (Z-1926-2008) | Medtronic Perfusion Systems | 2008-07-24 |