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FDA 510(k)

HARMAC THERMODILUTION CATHETER

K-Number: K963336 · 1997-08-14

ApplicantHarmac Medical Products, Inc.
Decision Date1997-08-14
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARMAC THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Harmac Medical Products, Inc.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K963336. 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 HARMAC THERMODILUTION CATHETER?

HARMAC THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Harmac Medical Products, Inc.. The 510(k) number is K963336.

When did HARMAC THERMODILUTION CATHETER receive FDA 510(k) clearance?

HARMAC THERMODILUTION CATHETER received FDA 510(k) clearance on 1997-08-14, under 510(k) number K963336.

Who is the listed applicant for HARMAC THERMODILUTION CATHETER?

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

What is the FDA product code for HARMAC THERMODILUTION CATHETER?

The FDA product code for HARMAC THERMODILUTION CATHETER 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 Harmac Medical Products, 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.

K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001K962829HARMAC BALLOON ANGIOGRAPHIC CATHETERK963335HARMAC BALLOON WEDGE PRESSURE CATHETERK962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONK963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLETK963074HARMAC QUADPOLAR MAPPING PACING CATHETER

View all 8 devices →

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.

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