The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Capiox Fx Hollow Fiber Oxygenator W/ Reservoir.
| Device ID | K130280 |
| 510k Number | K130280 |
| Device Name: | CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Garry A Courtney, Mba, Rac |
| Correspondent | Garry A Courtney, Mba, Rac TERUMO Corporation 125 Blue Ball Road 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 | 2013-02-05 |
| Decision Date | 2013-03-13 |
| Summary: | summary |