CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
FDA 510(k) clearance K130359 · decided 2013-03-13
Clearance details
- K-number
- K130359
- Device name
- CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-13
- Decision date
- 2013-03-13
- Days to decision
- 28 days
- Clearance type
- Special
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.