The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Cannula-tubing.
Device ID | K872033 |
510k Number | K872033 |
Device Name: | BIO-MEDICUS CANNULA-TUBING |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
Contact | Gregory W Sachs |
Correspondent | Gregory W Sachs BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-27 |
Decision Date | 1987-12-07 |