Cleared Special

EmeryGlide? (EG18008901)

K253262 · Nano4imaging GmbH · Cardiovascular
Mar 2026
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K253262 is an FDA 510(k) clearance for the EmeryGlide? (EG18008901), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Nano4imaging GmbH (Duesseldorf, DE). The FDA issued a Cleared decision on March 6, 2026, 158 days after receiving the submission on September 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K253262 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date March 06, 2026
Days to Decision 158 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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