The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox E Hollow Fiber Oxygenator With Integrated Heat Exchanger/arterial Reservoir.
| Device ID | K970463 |
| 510k Number | K970463 |
| Device Name: | CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-05-06 |
| Summary: | summary |