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FDA 510(k) Application Details - K171290
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
More FDA Info for this Device
510(K) Number
K171290
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Curatia Medical
3227 Kifer Road
Santa Clara, CA 95051 US
Other 510(k) Applications for this Company
Contact
Jessica Chiu
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
05/02/2017
Decision Date
07/19/2017
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
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