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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 K192195
Device Name Sterile Dilator
Applicant
Galt Medical Corp.
2220 Merritt Dr.
Garland,  TX  75041
Applicant Contact David Derrick
Correspondent
Galt Medical Corp.
2220 Merritt Dr.
Garland,  TX  75041
Correspondent Contact David Derrick
Regulation Number870.1310
Classification Product Code
DRE  
Subsequent Product Code
DYB  
Date Received08/13/2019
Decision Date 09/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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