The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic 7f And 8f Zuma Guiding Catheter.
Device ID | K982883 |
510k Number | K982883 |
Device Name: | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 35-37A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Mark Chartier |
Correspondent | Mark Chartier MEDTRONICS INTERVENTIONAL VASCULAR 35-37A CHERRY HILL DR. Danvers, MA 01923 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-17 |
Decision Date | 1998-09-04 |
Summary: | summary |