CHURCHILL INTER-CARDIAC SUCKER
FDA 510(k) clearance K872043 · decided 1987-09-30
Clearance details
- K-number
- K872043
- Device name
- CHURCHILL INTER-CARDIAC SUCKER
- Applicant
- Churchill Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-27
- Decision date
- 1987-09-30
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.