Cleared Traditional

ProTrack Pigtail Wire

K213898 · Baylis Medical Company, Inc. · Cardiovascular
Mar 2023
Decision
442d
Days
Class 2
Risk

About This 510(k) Submission

K213898 is an FDA 510(k) clearance for the ProTrack Pigtail Wire, 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 March 1, 2023, 442 days after receiving the submission on December 14, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K213898 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2021
Decision Date March 01, 2023
Days to Decision 442 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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