FDA 510(k) Application Details - K011056

Device Classification Name	More FDA Info for this Device
510(K) Number	K011056
Device Name	ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
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	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2001
Decision Date	10/24/2001
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