The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Hollow Oxygenator Circuit.
| Device ID | K812659 |
| 510k Number | K812659 |
| Device Name: | TERUMO HOLLOW OXYGENATOR CIRCUIT |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-18 |
| Decision Date | 1981-12-14 |