FDA 510(k) Application Details - K972684

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K972684
Device Name	Introducer, Catheter
Applicant	INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	RICK GAYKOWSKI Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/1997
Decision Date	10/10/1997
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