The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Vascular - Hub Material Modification To The 5f And 8f Launcher(r) Guide Catheters.
Device ID | K103386 |
510k Number | K103386 |
Device Name: | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers, MA 01923 -5186 |
Contact | Anu Gaur |
Correspondent | Anu Gaur MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers, MA 01923 -5186 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-18 |
Decision Date | 2011-02-11 |
Summary: | summary |