The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Fx05 Hollow Fiber Oxygenator With Integrated Arterial Filter.
| Device ID | K071572 |
| 510k Number | K071572 |
| Device Name: | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A 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 | 2007-06-08 |
| Decision Date | 2007-07-23 |
| Summary: | summary |