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FDA 510(k)

MEDTRONIC S3 TM SYSTEM

K-Number: K821004 · 1982-05-25

ApplicantMedtronic Vascular
Decision Date1982-05-25
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC S3 TM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1982-05-25 under 510(k) number K821004. 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 MEDTRONIC S3 TM SYSTEM?

MEDTRONIC S3 TM SYSTEM is a medical device that received FDA 510(k) clearance on 1982-05-25. The listed applicant is Medtronic Vascular. The 510(k) number is K821004.

When did MEDTRONIC S3 TM SYSTEM receive FDA 510(k) clearance?

MEDTRONIC S3 TM SYSTEM received FDA 510(k) clearance on 1982-05-25, under 510(k) number K821004.

Who is the listed applicant for MEDTRONIC S3 TM SYSTEM?

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

What is the FDA product code for MEDTRONIC S3 TM SYSTEM?

The FDA product code for MEDTRONIC S3 TM SYSTEM is DYG.

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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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