Thoratec CentriMag Return (Arterial) Cannula Kit
FDA 510(k) clearance K152161 · decided 2015-09-18
Clearance details
- K-number
- K152161
- Device name
- Thoratec CentriMag Return (Arterial) Cannula Kit
- Applicant
- Thoratec Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-08-03
- Decision date
- 2015-09-18
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.