The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capiox Sx18 Hollow Fiber Oxygenator With Detachable Hardshell Reservoir, Capiox Sx25 Hollow Fiber Oxgenator With Detacha.
| Device ID | K130359 |
| 510k Number | K130359 |
| Device Name: | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Suzanne Grenier |
| Correspondent | Suzanne Grenier TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-02-13 |
| Decision Date | 2013-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450160 | K130359 | 000 |
| 50699753450092 | K130359 | 000 |
| 50699753450078 | K130359 | 000 |
| 50699753450054 | K130359 | 000 |
| 50699753450030 | K130359 | 000 |