FDA 510(k) Application Details - K982141

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K982141
Device Name	Catheter, Embolectomy
Applicant	ARROW INTL., INC. 2400 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	870.5150   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	06/17/1998
Decision Date	08/31/1998
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