Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002

K-Number: K071140 · 2007-06-07

ApplicantTop Spins, Inc.
Decision Date2007-06-07
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 is the device name listed in this FDA 510(k) record. The listed applicant is Top Spins, Inc.. It received FDA 510(k) clearance on 2007-06-07 under 510(k) number K071140. 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 MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002?

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 is a medical device that received FDA 510(k) clearance on 2007-06-07. The listed applicant is Top Spins, Inc.. The 510(k) number is K071140.

When did MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 receive FDA 510(k) clearance?

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 received FDA 510(k) clearance on 2007-06-07, under 510(k) number K071140.

Who is the listed applicant for MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002?

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

What is the FDA product code for MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002?

The FDA product code for MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 is KCY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Top Spins, 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.

K151250Smart SetK972663SMART SET

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, LLCK050411ZIMMER 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.

↑