X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
FDA 510(k) clearance K993772 · decided 2000-06-05
Clearance details
- K-number
- K993772
- Device name
- X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-08
- Decision date
- 2000-06-05
- Days to decision
- 210 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 Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 recall (Z-0842-2012) | Terumo Cardiovascular Corporation | 2012-01-24 |