FDA 510(k) Application Details - K012256

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K012256
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	VASCUMETRIX, LLC 2824 N. POWER RD. SUITE 113-278 MEAS, AZ 85215-1674 US Other 510(k) Applications for this Company
Contact	MIKE HAMMONS 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	07/18/2001
Decision Date	12/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review