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FDA 510(k)

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

K-Number: K173563 · 2018-01-10

ApplicantTz Medical, Inc.
Decision Date2018-01-10
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K173563. 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 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE?

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Tz Medical, Inc.. The 510(k) number is K173563.

When did ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE receive FDA 510(k) clearance?

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE received FDA 510(k) clearance on 2018-01-10, under 510(k) number K173563.

Who is the listed applicant for ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE?

The FDA 510(k) record lists Tz Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE?

The FDA product code for ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE is DXC.

Other records listing Tz Medical, Inc. 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.

K252772Arc Adjustable Radial Cuff Compression DevicePMA P200005Automated external defibrillators (non-wearable)K163322TZ SKULL PIN Adult

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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