FDA 510(k) Application Details - K043387

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K043387
Device Name	Catheter, Percutaneous
Applicant	VASCON LLC 9344 NW 13TH STREET MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	STEPHEN F VADAS Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2004
Decision Date	02/16/2005
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