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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K182660
Device Name GaltTWS
Applicant
Galt Medical Corp.
2220 Merritt Dr.
Garland,  TX  75087
Applicant Contact David Derrick
Correspondent
Galt Medical Corp.
2220 Merritt Dr.
Garland,  TX  75087
Correspondent Contact David Derrick
Regulation Number870.1380
Classification Product Code
DRB  
Subsequent Product Codes
DQX   DTL  
Date Received09/25/2018
Decision Date 05/30/2019
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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