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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
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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