PROTEK Duo 31 Fr. Veno-Venous Cannula Set
FDA 510(k) clearance K160257 · decided 2016-03-04
Clearance details
- K-number
- K160257
- Device name
- PROTEK Duo 31 Fr. Veno-Venous Cannula Set
- Applicant
- Cardiacassist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-01
- Decision date
- 2016-03-04
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.