DIRECTFLOW ARTERIAL CANNULA
FDA 510(k) clearance K990772 · decided 1999-03-23
Clearance details
- K-number
- K990772
- Device name
- DIRECTFLOW ARTERIAL CANNULA
- Applicant
- Heartport, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-09
- Decision date
- 1999-03-23
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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