MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
FDA 510(k) clearance K000776 · decided 2001-02-07
Clearance details
- K-number
- K000776
- Device name
- MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
- Applicant
- Medtronic Cardiac Surgical Products
- Decision
- Substantially Equivalent
- Date received
- 2000-03-10
- Decision date
- 2001-02-07
- Days to decision
- 334 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 Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, recall (Z-0997-2014) | Medtronic Inc. Cardiac Rhythm Disease Management | 2014-02-20 |