FDA 510(k) Application Details - K971719

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K971719
Device Name	Wire, Guide, Catheter
Applicant	THEROX, INC. 2025 NEWPORT BLVD SUITE 200 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	PAUL J ZALESKY Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/1997
Decision Date	11/03/1997
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