The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corp. with the FDA for Capiox Fx15 And Fx25 Hollow Fiber Oxygenator/reservoir.
| Device ID | K130520 |
| 510k Number | K130520 |
| Device Name: | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka, JP 418-0015 |
| Contact | Eileen Dorsey |
| Correspondent | Eileen Dorsey ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka, JP 418-0015 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-02-28 |
| Decision Date | 2013-03-13 |
| Summary: | summary |