The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox(r) Bubble Trap.
| Device ID | K911632 |
| 510k Number | K911632 |
| Device Name: | CAPIOX(R) BUBBLE TRAP |
| Classification | Detector, Bubble, Cardiopulmonary Bypass |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | George S Momoda |
| Correspondent | George S Momoda TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-07-09 |