The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Circuit Connectors.
| Device ID | K073474 |
| 510k Number | K073474 |
| Device Name: | CAPIOX CIRCUIT CONNECTORS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry Courtney |
| Correspondent | Garry Courtney TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-11 |
| Decision Date | 2008-03-05 |
| Summary: | summary |