FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K Number: K130520
·
Decision Mar 13, 2013
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K Number
- K130520
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ashitaka Factory of Terumo Corp.
- Date Received
- February 28, 2013
- Decision Date
- March 13, 2013
- Product Code
- DTZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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