The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Zuma Guiding Catheter.
Device ID | K981198 |
510k Number | K981198 |
Device Name: | MEDTRONIC ZUMA GUIDING CATHETER |
Classification | Catheter, Percutaneous |
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 | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-02 |
Decision Date | 1998-08-07 |
Summary: | summary |