Cleared Traditional

Mechanical Guidewire

K221351 · Baylis Medical Company, Inc. · Cardiovascular
Dec 2022
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K221351 is an FDA 510(k) clearance for the Mechanical Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on December 19, 2022, 223 days after receiving the submission on May 10, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K221351 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2022
Decision Date December 19, 2022
Days to Decision 223 days
Submission Type Traditional
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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