Cleared Special

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

K180795 · Boston Scientific · Cardiovascular
Apr 2018
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K180795 is an FDA 510(k) clearance for the JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Boston Scientific (Maple Gove, US). The FDA issued a Cleared decision on April 12, 2018, 16 days after receiving the submission on March 27, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K180795 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2018
Decision Date April 12, 2018
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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