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FDA 510(k)

VELCRO TOURNIQUET

K-Number: K853537 · 1985-09-12

ApplicantCp Medical
Decision Date1985-09-12
Product CodeGAX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VELCRO TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 1985-09-12 under 510(k) number K853537. The device is classified under product code GAX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELCRO TOURNIQUET?

VELCRO TOURNIQUET is a medical device that received FDA 510(k) clearance on 1985-09-12. The listed applicant is Cp Medical. The 510(k) number is K853537.

When did VELCRO TOURNIQUET receive FDA 510(k) clearance?

VELCRO TOURNIQUET received FDA 510(k) clearance on 1985-09-12, under 510(k) number K853537.

Who is the listed applicant for VELCRO TOURNIQUET?

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

What is the FDA product code for VELCRO TOURNIQUET?

The FDA product code for VELCRO TOURNIQUET is GAX.

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 Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

View all 31 devices →

Related Devices (Code: GAX)

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.

K931198UNIQUETIcat SystemsK881398TOURNIQUETBarretta Products, Research and Development, Inc.K881176STERILE ESMARCH BANDAGESpectrum/Hydro-Med Products, Inc.K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.K873928UNIVERSAL TOURNIQUETDryden Corp.K872003KINDERWRAPThe Kinder Co.

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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