CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
FDA 510(k) clearance K071494 · decided 2007-07-16
Clearance details
- K-number
- K071494
- Device name
- CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
- Applicant
- Terumo Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-30
- Decision date
- 2007-07-16
- Days to decision
- 47 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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