Cleared Traditional

Columbus Guidewire

K200374 · Rapid Medical , Ltd. · Neurology
Dec 2020
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K200374 is an FDA 510(k) clearance for the Columbus 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 December 14, 2020, 304 days after receiving the submission on February 14, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K200374 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2020
Decision Date December 14, 2020
Days to Decision 304 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