The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Optima Xp Hollow Fiber Membrane Oxygenator.
Device ID | K963518 |
510k Number | K963518 |
Device Name: | COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
Contact | Mary L Armstrong |
Correspondent | Mary L Armstrong COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-03 |
Decision Date | 1997-12-08 |
Summary: | summary |