The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Terumo Hollow Fiber Oxygenator.
Device ID | K802970 |
510k Number | K802970 |
Device Name: | TERUMO HOLLOW FIBER OXYGENATOR |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-21 |
Decision Date | 1981-01-22 |