FDA 510(k)

ATS 5000 Automatic Tourniquet Instrument

K-Number: K202919 · 2021-05-20

ApplicantMcewen and Associates Consulting , Ltd.

Decision Date2021-05-20

Product CodeKCY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ATS 5000 Automatic Tourniquet Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Mcewen and Associates Consulting , Ltd.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K202919. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS 5000 Automatic Tourniquet Instrument?

ATS 5000 Automatic Tourniquet Instrument is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Mcewen and Associates Consulting , Ltd.. The 510(k) number is K202919.

When did ATS 5000 Automatic Tourniquet Instrument receive FDA 510(k) clearance?

ATS 5000 Automatic Tourniquet Instrument received FDA 510(k) clearance on 2021-05-20, under 510(k) number K202919.

Who is the listed applicant for ATS 5000 Automatic Tourniquet Instrument?

The FDA 510(k) record lists Mcewen and Associates Consulting , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATS 5000 Automatic Tourniquet Instrument?

The FDA product code for ATS 5000 Automatic Tourniquet Instrument is KCY.

Related Devices (Code: KCY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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