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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K173287
Device Name Elite HV Radial
Galt Medical Corp.
2220 Merritt Drive
Garland,  TX  75087
Applicant Contact David Derrick
Galt Medical Corp.
2220 Merritt Drive
Garland,  TX  75087
Correspondent Contact David Derrick
Regulation Number870.1340
Classification Product Code
Subsequent Product Code
Date Received10/16/2017
Decision Date 12/21/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls