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 |