COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
FDA 510(k) clearance K000977 · decided 2001-03-23
Clearance details
- K-number
- K000977
- Device name
- COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
- Applicant
- Olson Medical Sales, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-27
- Decision date
- 2001-03-23
- Days to decision
- 361 days
- Clearance type
- Traditional
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure recall (Z-0298-03) | Terumo Cardiovascular Systems Corp | 2003-04-03 |