SeQure® NF and SeQure® Microcatheters

FDA 510(k) K173430 · Accurate Medical Therapeutics, Ltd.

Substantially Equivalent

510(k) numberK173430

Submission

Device name
SeQure® NF and SeQure® Microcatheters
Applicant
Accurate Medical Therapeutics, Ltd.
Tel-Aviv, IL
Received
November 2, 2017
Decision date
January 26, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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Questions and answers

When was SeQure® NF and SeQure® Microcatheters cleared by the FDA?

SeQure® NF and SeQure® Microcatheters (K173430) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 85 days after the submission was received.

What is the product code of K173430?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.