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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 K173423
Device Name MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
Applicant
Nano4imaging GmbH
Pauwelsstrasse 17
Aachen,  DE 52074
Applicant Contact Christoph R. Manegold
Correspondent
G & L Scientific
9 Highland Ave.
Derry,  NH  03038
Correspondent Contact Judith Harrington
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/01/2017
Decision Date 11/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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