ProtekDuo Veno-Venous Cannula Sets
FDA 510(k) clearance K232480 · decided 2023-10-06
Clearance details
- K-number
- K232480
- Device name
- ProtekDuo Veno-Venous Cannula Sets
- Applicant
- Cardiacassist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-16
- Decision date
- 2023-10-06
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- PZS
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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| MC3 Crescent Jugular Dual Lumen Catheter (K203409) | Mc3, Inc. | 2021-05-03 |
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Recalls involving this device
No recalls on record reference this clearance.