FDA 510(k) Application Details - K003394

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K003394
Device Name	Wire, Guide, Catheter
Applicant	NIPRO MEDICAL CORP. 3150 NW 107 AVE.. MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	CARY GOLDSMITH 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	11/01/2000
Decision Date	01/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review