HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
FDA 510(k) clearance K013393 · decided 2001-11-09
Clearance details
- K-number
- K013393
- Device name
- HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
- Applicant
- A-Med Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-15
- Decision date
- 2001-11-09
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.