The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Stent Support Guide Catheter.
Device ID | K010579 |
510k Number | K010579 |
Device Name: | STENT SUPPORT GUIDE CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Fred L Boucher |
Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-27 |
Decision Date | 2001-11-21 |