SimplGuide

FDA 510(k) K261242 · Pendracare

Substantially Equivalent

510(k) numberK261242

Submission

Device name
SimplGuide
Applicant
Pendracare
Leek, NL
Received
April 15, 2026
Decision date
June 25, 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
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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Questions and answers

When was SimplGuide cleared by the FDA?

SimplGuide (K261242) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 71 days after the submission was received.

What is the product code of K261242?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.