FDA 510(k) Application Details - K965209

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K965209
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	ARROW INTL., INC. 9 PLYMOUTH ST. EVERETT, MA 02149 US Other 510(k) Applications for this Company
Contact	MICHAEL JESI Other 510(k) Applications for this Contact
Regulation Number	870.3535   More FDA Info for this Regulation Number
Classification Product Code	DSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/1996
Decision Date	01/23/1998
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