CentriMag Acute Circulatory Support System
FDA 510(k) clearance K191557 · decided 2019-07-10
Clearance details
- K-number
- K191557
- Device name
- CentriMag Acute Circulatory Support System
- Applicant
- Thoratec Corporation (Now Part of Abbott)
- Decision
- Substantially Equivalent
- Date received
- 2019-06-12
- Decision date
- 2019-07-10
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- 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.