FDA 510(k) Application Details - K040519

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K040519
Device Name	Catheter, Straight
Applicant	PERCUTANEOUS SYSTEMS, INC. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2004
Decision Date	05/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review