FDA 510(k) Application Details - K981441

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K981441
Device Name	Catheter, Intravascular, Diagnostic
Applicant	TRINITY LABORATORIES, INC. 201 KILEY DR. SALISBURY, MD 21801 US Other 510(k) Applications for this Company
Contact	PARTHA BASUMALLIK Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/1998
Decision Date	07/10/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review