The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 5f Sherpa Active Nx Guide Catheter.
Device ID | K062420 |
510k Number | K062420 |
Device Name: | 5F SHERPA ACTIVE 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 | 2006-08-18 |
Decision Date | 2006-09-08 |
Summary: | summary |