FDA 510(k) Application Details - K172487

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K172487
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	Galt Medical Corp. 2220 Merritt Dr. Garland, TX 75041 US Other 510(k) Applications for this Company
Contact	David Derrick Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2017
Decision Date	10/16/2017
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review