The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 8f Sherpa Nx Guide Catheter.
Device ID | K060418 |
510k Number | K060418 |
Device Name: | 8F SHERPA NX GUIDE CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Mark Puopolo |
Correspondent | Mark Puopolo MEDTRONIC VASCULAR 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 | 2006-02-17 |
Decision Date | 2006-03-15 |
Summary: | summary |