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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K171290
Device Name Vela RX PTA Balloon Dilatation Catheter
Applicant
Curatia Medical
3227 Kifer Rd.
Santa Clara,  CA  95051
Applicant Contact Jessica Chiu
Correspondent
Jcq Consulting
11218 Zest Court
Anoka,  MN  55449
Correspondent Contact Bill Jacqmein
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/02/2017
Decision Date 07/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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