FDA 510(k) Application Details - K963920

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K963920
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	ARROW INTL., INC. 3000 BERNVILLE RD. READING, PA 19605 US Other 510(k) Applications for this Company
Contact	THOMAS D NICKEL 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	09/30/1996
Decision Date	06/17/1997
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