The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Fx15 And Fx25 Hollow Fiber Oxygenator And Arterial Filter.
| Device ID | K071494 |
| 510k Number | K071494 |
| Device Name: | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Gary Courtney |
| Correspondent | Gary Courtney TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-30 |
| Decision Date | 2007-07-16 |
| Summary: | summary |