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FDA 510(k)

SAM JUNCTIONAL TOURNIQUET

K-Number: K123694 · 2013-03-07

ApplicantSam Medical Products
Decision Date2013-03-07
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAM JUNCTIONAL TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Sam Medical Products. It received FDA 510(k) clearance on 2013-03-07 under 510(k) number K123694. 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 SAM JUNCTIONAL TOURNIQUET?

SAM JUNCTIONAL TOURNIQUET is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Sam Medical Products. The 510(k) number is K123694.

When did SAM JUNCTIONAL TOURNIQUET receive FDA 510(k) clearance?

SAM JUNCTIONAL TOURNIQUET received FDA 510(k) clearance on 2013-03-07, under 510(k) number K123694.

Who is the listed applicant for SAM JUNCTIONAL TOURNIQUET?

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

What is the FDA product code for SAM JUNCTIONAL TOURNIQUET?

The FDA product code for SAM JUNCTIONAL TOURNIQUET 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.

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Other records listing Sam Medical Products 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.

K131561SAM JUNCTIONAL TOURNIQUETK102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

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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