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FDA 510(k)

Vein Clamps, Artery Clamps

K-Number: K161315 · 2016-08-18

ApplicantAros Surgical Instruments Corporation
Decision Date2016-08-18
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vein Clamps, Artery Clamps is the device name listed in this FDA 510(k) record. The listed applicant is Aros Surgical Instruments Corporation. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K161315. 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 Vein Clamps, Artery Clamps?

Vein Clamps, Artery Clamps is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Aros Surgical Instruments Corporation. The 510(k) number is K161315.

When did Vein Clamps, Artery Clamps receive FDA 510(k) clearance?

Vein Clamps, Artery Clamps received FDA 510(k) clearance on 2016-08-18, under 510(k) number K161315.

Who is the listed applicant for Vein Clamps, Artery Clamps?

The FDA 510(k) record lists Aros Surgical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein Clamps, Artery Clamps?

The FDA product code for Vein Clamps, Artery Clamps is DXC.

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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