Soldier Microcatheter

FDA 510(k) K232536 · Embolx, Inc.

Substantially Equivalent

510(k) numberK232536

Submission

Device name
Soldier Microcatheter
Applicant
Embolx, Inc.
Sunnyvale, CA, US
Received
August 21, 2023
Decision date
February 23, 2024
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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K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
K232573INFINITI™ Ambi Angiographic CatheterDQO · Traditional Cordis US Corp11/21/2023SE
K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional Gentuity, LLC08/08/2023SE

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Questions and answers

When was Soldier Microcatheter cleared by the FDA?

Soldier Microcatheter (K232536) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 186 days after the submission was received.

What is the product code of K232536?

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