The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Rx25 Hollow Fiber Oxygenator W/wo Hardshell Reservoir.
| Device ID | K040210 |
| 510k Number | K040210 |
| Device Name: | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO 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 | Yes |
| Date Received | 2004-01-30 |
| Decision Date | 2004-03-03 |
| Summary: | summary |