FDA 510(k) Application Details - K970229

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K970229
Device Name	Introducer, Catheter
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	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/1997
Decision Date	02/13/1998
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