Attain Hybrid Guide Wire

Wire, Guide, Catheter

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Attain Hybrid Guide Wire.

Device ID	K143316
510k Number	K143316
Device Name:	Attain Hybrid Guide Wire
Classification	Wire, Guide, Catheter
Applicant	Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
Contact	Mia Hunt
Correspondent	Mia Hunt Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
Product Code	DQX
CFR Regulation Number	870.1330 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2014-11-19
Decision Date	2015-03-11
Summary:	summary