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 |