FDA 510(k) Application Details - K101062

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K101062
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 PLEASANTON, CA 94566 US Other 510(k) Applications for this Company
Contact	SHIVA ARDAKANI 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	04/16/2010
Decision Date	05/12/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review