EmeryGlide™ (EG18008901)

FDA 510(k) K253262 · Nano4imaging GmbH

Substantially Equivalent

510(k) numberK253262

Submission

Device name
EmeryGlide™ (EG18008901)
Applicant
Nano4imaging GmbH
Duesseldorf, DE
Received
September 29, 2025
Decision date
March 6, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQX – Wire, Guide, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

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Questions and answers

When was EmeryGlide™ (EG18008901) cleared by the FDA?

EmeryGlide™ (EG18008901) (K253262) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 158 days after the submission was received.

What is the product code of K253262?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.