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FDA 510(k)

RADIAL ARTERY COMPRESSION TOURNIQUET

K-Number: K111837 · 2011-09-27

ApplicantLepu Medical Technology (Beijing) Co., Ltd.
Decision Date2011-09-27
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIAL ARTERY COMPRESSION TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2011-09-27 under 510(k) number K111837. 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 TOURNIQUET?

RADIAL ARTERY COMPRESSION TOURNIQUET is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K111837.

When did RADIAL ARTERY COMPRESSION TOURNIQUET receive FDA 510(k) clearance?

RADIAL ARTERY COMPRESSION TOURNIQUET received FDA 510(k) clearance on 2011-09-27, under 510(k) number K111837.

Who is the listed applicant for RADIAL ARTERY COMPRESSION TOURNIQUET?

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

What is the FDA product code for RADIAL ARTERY COMPRESSION TOURNIQUET?

The FDA product code for RADIAL ARTERY COMPRESSION TOURNIQUET is DXC.

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Other records listing Lepu Medical Technology (Beijing) Co., Ltd. as applicant

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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

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

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