NHanceIT

FDA 510(k) K260559 · IMDS Operation B.V.

Substantially Equivalent

510(k) numberK260559

Submission

Device name
NHanceIT
Applicant
IMDS Operation B.V.
Roden, NL
Received
February 19, 2026
Decision date
August 14, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was NHanceIT cleared by the FDA?

NHanceIT (K260559) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 176 days after the submission was received.

What is the product code of K260559?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.