SELECT 3D ARTERIAL CANNULA
FDA 510(k) clearance K043179 · decided 2005-02-08
Clearance details
- K-number
- K043179
- Device name
- SELECT 3D ARTERIAL CANNULA
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-11-17
- Decision date
- 2005-02-08
- Days to decision
- 83 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 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). N recall (Z-0995-2014) | Medtronic Inc. Cardiac Rhythm Disease Management | 2014-02-20 |