The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Capiox Cardiotomy Reservoir.
| Device ID | K033800 |
| 510k Number | K033800 |
| Device Name: | CAPIOX CARDIOTOMY RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-05 |
| Decision Date | 2004-02-10 |
| Summary: | summary |