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FDA 510(k)

EZ VEIN INFLATABLE TOURNIQUET

K-Number: K112874 · 2011-10-17

ApplicantDominion Medical Devices, LLC
Decision Date2011-10-17
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EZ VEIN INFLATABLE TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Dominion Medical Devices, LLC. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K112874. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ VEIN INFLATABLE TOURNIQUET?

EZ VEIN INFLATABLE TOURNIQUET is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Dominion Medical Devices, LLC. The 510(k) number is K112874.

When did EZ VEIN INFLATABLE TOURNIQUET receive FDA 510(k) clearance?

EZ VEIN INFLATABLE TOURNIQUET received FDA 510(k) clearance on 2011-10-17, under 510(k) number K112874.

Who is the listed applicant for EZ VEIN INFLATABLE TOURNIQUET?

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

What is the FDA product code for EZ VEIN INFLATABLE TOURNIQUET?

The FDA product code for EZ VEIN INFLATABLE TOURNIQUET is KCY.

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K012632TOURNIQUET CUFF; PNEUMATIC TOURNIQUETMedical Instruments Technology, Inc.

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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