Cleared Traditional

Drivewire 24 Guidewire

K233791 · Rapid Medical , Ltd. · Neurology
Jul 2024
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K233791 is an FDA 510(k) clearance for the Drivewire 24 Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on July 11, 2024, 226 days after receiving the submission on November 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K233791 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2023
Decision Date July 11, 2024
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330