FDA 510(k) Application Details - K970938

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K970938
Device Name	Wire, Guide, Catheter
Applicant	BIOCOMPATIBLES CARDIOVASCULAR, INC. 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	NANCY F TEAGUE 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	03/13/1997
Decision Date	11/17/1997
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