FDA 510(k) Application Details - K021996

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K021996
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Bolton Medical, Inc. 16-00 POLLITT DR. FAIR LAWN, NJ 07410 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2002
Decision Date	08/23/2002
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