The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capiox Flexible Venous Reservoir.
| Device ID | K040023 |
| 510k Number | K040023 |
| Device Name: | CAPIOX FLEXIBLE VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 | Yes |
| Date Received | 2004-01-07 |
| Decision Date | 2004-03-01 |
| Summary: | summary |