The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Capiox Fx15 Advance Oxygenator With Integrated Arterial Filter And Hardshell Reservoir.
| Device ID | K151389 |
| 510k Number | K151389 |
| Device Name: | Terumo Capiox FX15 Advance Oxygenator With Integrated Arterial Filter And Hardshell Reservoir |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | DTZ |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450801 | K151389 | 000 |
| 50699753450788 | K151389 | 000 |