CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
FDA 510(k) clearance K051997 · decided 2005-09-15
Clearance details
- K-number
- K051997
- Device name
- CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-25
- Decision date
- 2005-09-15
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- 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 |
|---|---|---|
| Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications recall (Z-1523-2012) | Terumo Cardiovascular Systems Corp | 2012-05-11 |