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)

THERMOCATH

K-Number: K771306 · 1977-09-14

ApplicantVictory Engineering Corp.
Decision Date1977-09-14
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMOCATH is the device name listed in this FDA 510(k) record. The listed applicant is Victory Engineering Corp.. It received FDA 510(k) clearance on 1977-09-14 under 510(k) number K771306. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOCATH?

THERMOCATH is a medical device that received FDA 510(k) clearance on 1977-09-14. The listed applicant is Victory Engineering Corp.. The 510(k) number is K771306.

When did THERMOCATH receive FDA 510(k) clearance?

THERMOCATH received FDA 510(k) clearance on 1977-09-14, under 510(k) number K771306.

Who is the listed applicant for THERMOCATH?

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

What is the FDA product code for THERMOCATH?

The FDA product code for THERMOCATH is DYG.

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 Victory Engineering 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.

K772175CATHETER SYSTEM, COPE/EISENBERG

Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, LLC

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.

↑