Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Mcewen and Associates Consulting , Ltd.. It received FDA 510(k) clearance on 2021-05-20 under approval 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. It is manufactured by Mcewen and Associates Consulting , Ltd.. The 510(k) number is K202919.

When was ATS 5000 Automatic Tourniquet Instrument approved by the FDA?

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

What company makes ATS 5000 Automatic Tourniquet Instrument?

ATS 5000 Automatic Tourniquet Instrument is manufactured by Mcewen and Associates Consulting , Ltd..

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)

K162365T-CuffTerumobct, Inc.

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.

↑