DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k) clearance K011020 · decided 2001-06-01
Clearance details
- K-number
- K011020
- Device name
- DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- Applicant
- Denver Biomedicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-04
- Decision date
- 2001-06-01
- Days to decision
- 58 days
- Clearance type
- Special
- Product code
- KPM
- Device class
- 2
- Regulation number
- 876.5955
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.