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FDA 510(k)

Radial Artery Compression Tourniquets

K-Number: K222182 · 2023-01-04

ApplicantBeijing Demax Medical Technology Co.,Ltd
Decision Date2023-01-04
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radial Artery Compression Tourniquets is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K222182. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radial Artery Compression Tourniquets?

Radial Artery Compression Tourniquets is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K222182.

When did Radial Artery Compression Tourniquets receive FDA 510(k) clearance?

Radial Artery Compression Tourniquets received FDA 510(k) clearance on 2023-01-04, under 510(k) number K222182.

Who is the listed applicant for Radial Artery Compression Tourniquets?

The FDA 510(k) record lists Beijing Demax Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radial Artery Compression Tourniquets?

The FDA product code for Radial Artery Compression Tourniquets is DXC.

Related Clinical Trials

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.

NCT07621185Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial ProceduresCOMPLETEDNCT07686003Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial ArteriesNOT_YET_RECRUITING

Other records listing Beijing Demax Medical Technology Co.,Ltd as applicant

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.

K242248Introducer Sheath KitsK222184Introducer Sheath Kits

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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