CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
FDA 510(k) clearance K882758 · decided 1988-10-13
Clearance details
- K-number
- K882758
- Device name
- CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1988-07-05
- Decision date
- 1988-10-13
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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