The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Angiographic Catheter.
Device ID | K980973 |
510k Number | K980973 |
Device Name: | MEDTRONIC ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37-A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Mark Chartier |
Correspondent | Mark Chartier MEDTRONICS INTERVENTIONAL VASCULAR 37-A CHERRY HILL DR. Danvers, MA 01923 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-16 |
Decision Date | 1998-12-10 |
Summary: | summary |