The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Capiox Fx15 And Fx25 Hollow Fiber Oxygenator/reservoir.
| Device ID | K140774 |
| 510k Number | K140774 |
| Device Name: | TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Eileen Dorsey |
| Correspondent | Eileen Dorsey Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. 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 | 2014-03-28 |
| Decision Date | 2014-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450757 | K140774 | 000 |
| 00699753450745 | K140774 | 000 |
| 50699753450474 | K140774 | 000 |
| 50699753450467 | K140774 | 000 |
| 50699753450450 | K140774 | 000 |
| 50699753450443 | K140774 | 000 |