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FDA 510(k)

ProTrack Pigtail Wire

K-Number: K213898 · 2023-03-01

ApplicantBaylis Medical Company, Inc.
Decision Date2023-03-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ProTrack Pigtail Wire is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K213898. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProTrack Pigtail Wire?

ProTrack Pigtail Wire is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K213898.

When did ProTrack Pigtail Wire receive FDA 510(k) clearance?

ProTrack Pigtail Wire received FDA 510(k) clearance on 2023-03-01, under 510(k) number K213898.

Who is the listed applicant for ProTrack Pigtail Wire?

The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProTrack Pigtail Wire?

The FDA product code for ProTrack Pigtail Wire is DQX.

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Related Devices (Code: DQX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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