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FDA 510(k)

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

K-Number: K012632 · 2001-10-26

ApplicantMedical Instruments Technology, Inc.
Decision Date2001-10-26
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instruments Technology, Inc.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K012632. 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 TOURNIQUET CUFF; PNEUMATIC TOURNIQUET?

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Medical Instruments Technology, Inc.. The 510(k) number is K012632.

When did TOURNIQUET CUFF; PNEUMATIC TOURNIQUET receive FDA 510(k) clearance?

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012632.

Who is the listed applicant for TOURNIQUET CUFF; PNEUMATIC TOURNIQUET?

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

What is the FDA product code for TOURNIQUET CUFF; PNEUMATIC TOURNIQUET?

The FDA product code for TOURNIQUET CUFF; PNEUMATIC TOURNIQUET is KCY.

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Other records listing Medical Instruments Technology, 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.

K012614KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKINK012640ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDSK012624REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURSK884611THE ORTHORANGER II ELECTRONIC GONIOMETER

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.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.

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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