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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 K221390
Device Name BNLE Access Guidewire
Applicant
Biomerics Nle
10351 Xylon Ave. N
Suite 100
Brooklyn Park,  MN  55445
Applicant Contact Jason Albers
Correspondent
Medventure Health
299s Main St., Suite 2300
Salt Lake City,  UT  84111
Correspondent Contact Jonathan Holmes
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/13/2022
Decision Date 04/28/2023
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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