FDA 510(k) Application Details - K992368

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K992368
Device Name	Catheter, Embolectomy
Applicant	VASCUTECH, INC. 164 MIDDLESEX TURNPIKE BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	TRENT G KAMKE Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	DXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1999
Decision Date	12/09/1999
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