The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Femoral Cannula/introducer.
Device ID | K924642 |
510k Number | K924642 |
Device Name: | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
Contact | Thomas K Johnsen |
Correspondent | Thomas K Johnsen MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH 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 | 1992-09-14 |
Decision Date | 1993-03-26 |