The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Rx05 Hollow Fiber Oxygenator W/without Hardshell Reservoir.
| Device ID | K022115 |
| 510k Number | K022115 |
| Device Name: | CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO 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 | 2002-07-01 |
| Decision Date | 2002-09-27 |
| Summary: | summary |