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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 K253262
Device Name EmeryGlide™ (EG18008901)
Applicant
Nano4imaging GmbH
Life Science Centre
Merowingerplatz 1
Duesseldorf,  DE 40225
Applicant Contact Natalie Theisen
Correspondent
Nano4imaging GmbH
Life Science Centre
Merowingerplatz 1
Duesseldorf,  DE 40225
Correspondent Contact Natalie Theisen
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/29/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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