The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Extracorporeal Circuit With Bio-active Surface.
Device ID | K891687 |
510k Number | K891687 |
Device Name: | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Sharon Rockwell |
Correspondent | Sharon Rockwell MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-22 |
Decision Date | 1989-05-31 |