FDA 510(k) Application Details - K972610

Device Classification Name	More FDA Info for this Device
510(K) Number	K972610
Device Name	POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
Applicant	POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. MINNEAPOLIS, MN 55433-8003 US Other 510(k) Applications for this Company
Contact	JAMES D GUSTAFSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/1997
Decision Date	04/11/2000
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