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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K143135
Device Name Spring Coil Guidewire
Applicant
Neometrics, Inc.
2605 Fernbrook Ln.
Suite J
Plymouth,  MN  55447
Applicant Contact Gene Champeau
Correspondent
Neometrics, Inc.
2605 Fernbrook Ln.
Suite J
Plymouth,  MN  55447
Correspondent Contact Gene Champeau
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/31/2014
Decision Date 02/20/2015
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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