The following data is part of a premarket notification filed by Terumo Cardiovascular Systems with the FDA for Capiox Bubble Trap With X-coating.
| Device ID | K090698 |
| 510k Number | K090698 |
| Device Name: | CAPIOX BUBBLE TRAP WITH X-COATING |
| Classification | Detector, Bubble, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-17 |
| Decision Date | 2009-06-08 |
| Summary: | summary |