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 |