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 Reservoir, Terumo Capiox Fx25 Advance Oxygenator With Integrated Arterial Filter And Reservoir.
| Device ID | K151791 |
| 510k Number | K151791 |
| Device Name: | Terumo Capiox FX15 Advance Oxygenator With Integrated Arterial Filter And Reservoir, Terumo Capiox FX25 Advance Oxygenator With Integrated Arterial Filter And Reservoir |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 125 BLUE BALL ROAD Elkton, MD 21921 |
| Contact | Jaime Lee |
| Correspondent | Jaime Lee 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450832 | K151791 | 000 |
| 50699753450825 | K151791 | 000 |
| 50699753450818 | K151791 | 000 |
| 50699753450795 | K151791 | 000 |