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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K192283
Device Name MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
Applicant
Medron, LLC
1518 S Gladiola St.
Salt Lake City,  UT  84104
Applicant Contact David Kujawa
Correspondent
Medron, LLC
1518 S Gladiola St.
Salt Lake City,  UT  84104
Correspondent Contact David Kujawa
Regulation Number870.1310
Classification Product Code
DRE  
Date Received08/22/2019
Decision Date 05/06/2020
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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