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FDA 510(k)

HEPARIN COATED BALLOON THERMODILU

K-Number: K834037 · 1984-01-10

ApplicantNova Medical Specialties
Decision Date1984-01-10
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEPARIN COATED BALLOON THERMODILU is the device name listed in this FDA 510(k) record. The listed applicant is Nova Medical Specialties. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K834037. 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 HEPARIN COATED BALLOON THERMODILU?

HEPARIN COATED BALLOON THERMODILU is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Nova Medical Specialties. The 510(k) number is K834037.

When did HEPARIN COATED BALLOON THERMODILU receive FDA 510(k) clearance?

HEPARIN COATED BALLOON THERMODILU received FDA 510(k) clearance on 1984-01-10, under 510(k) number K834037.

Who is the listed applicant for HEPARIN COATED BALLOON THERMODILU?

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

What is the FDA product code for HEPARIN COATED BALLOON THERMODILU?

The FDA product code for HEPARIN COATED BALLOON THERMODILU is DYG.

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Other records listing Nova Medical Specialties 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.

K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHK853625NOVA ARTERIAL EMBOLECTOMY CATHETERK840009NOVA 12 CARDIAC OUTPUT COMPUTERK841639NOVA BALLOON THERMODILUTION CATH.K841640NOVA BALLOON THERMODILUTION INFUSION

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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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