NIKKISO NK PUMP
FDA 510(k) clearance K920077 · decided 1993-09-29
Clearance details
- K-number
- K920077
- Device name
- NIKKISO NK PUMP
- Applicant
- International Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-08
- Decision date
- 1993-09-29
- Days to decision
- 630 days
- Clearance type
- Traditional
- Product code
- DWD
- Device class
- 2
- Regulation number
- 870.4430
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.