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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 K232662
Device Name BNLE Hydrophilic Jacketed Peripheral Guidewire
Applicant
Biomerics Nle
10351 Xylon Ave. N., Suite 160
Brooklyn Park,  MN  55445
Applicant Contact Maggie Goshert
Correspondent
Canyon Labs
16217 S Bringhurst Dr., Suite 600
Bluffdale,  UT  84065
Correspondent Contact Brandie Moore
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/31/2023
Decision Date 05/14/2024
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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