Cleared Traditional

RADIFOCUS Torque Device

K220934 · Terumo Medical Products Hangzhou Co., Ltd. · Neurology
Jun 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K220934 is an FDA 510(k) clearance for the RADIFOCUS Torque Device, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 29, 2022, 90 days after receiving the submission on March 31, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K220934 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2022
Decision Date June 29, 2022
Days to Decision 90 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