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FDA 510(k)

THE CIRCULATOR BOOT

K-Number: K792354 · 1980-01-09

ApplicantCirculator Boot Corp.
Decision Date1980-01-09
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CIRCULATOR BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Circulator Boot Corp.. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792354. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CIRCULATOR BOOT?

THE CIRCULATOR BOOT is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Circulator Boot Corp.. The 510(k) number is K792354.

When did THE CIRCULATOR BOOT receive FDA 510(k) clearance?

THE CIRCULATOR BOOT received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792354.

Who is the listed applicant for THE CIRCULATOR BOOT?

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

What is the FDA product code for THE CIRCULATOR BOOT?

The FDA product code for THE CIRCULATOR BOOT is DRN.

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 Circulator Boot Corp. 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.

K082134CIRCULATOR BOOTK971026THE CIRCULATOR BOOTK833627CIRCULATOR MINIBOOT

Related Devices (Code: DRN)

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.

K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd.K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLCK130439EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGChongqing Psk Sci-Tech Development Co., Ltd.

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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