FDA 510(k) Application Details - K974617

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K974617
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	ENDOVASCULAR INSTRUMENTS, INC. 1800 EAST 900 SOUTH SALTLAKE CITY, UT 84108 US Other 510(k) Applications for this Company
Contact	JACK SPEER 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	12/11/1997
Decision Date	12/01/1998
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