The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Sherpa Guiding Catheter With Catheter Introducer.
Device ID | K915351 |
510k Number | K915351 |
Device Name: | SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Kirk Daly |
Correspondent | Kirk Daly MEDTRONICS INTERVENTIONAL VASCULAR 37A 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 | 1991-11-26 |
Decision Date | 1992-06-29 |