Cleared Traditional

Soldier Microcatheter

K232536 · Embolx, Inc. · Cardiovascular

Feb 2024

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K232536 is an FDA 510(k) clearance for the Soldier Microcatheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Embolx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 23, 2024, 186 days after receiving the submission on August 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K232536 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2023
Decision Date	February 23, 2024
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF