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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K141354
Device Name NAVAJO PTA BALLOON DILATATION CATHETER
Applicant
Curative Medical, Inc.
1591 Deephaven Dr.
Woodbury,  MN  55129
Applicant Contact BILL JACQMEIN
Correspondent
Curative Medical, Inc.
1591 Deephaven Dr.
Woodbury,  MN  55129
Correspondent Contact BILL JACQMEIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/23/2014
Decision Date 01/30/2015
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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