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FDA 510(k)

FLOW-DIRECTED THERMODILUTION CATH

K-Number: K843409 · 1984-10-18

ApplicantAndover Medical, Inc.
Decision Date1984-10-18
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW-DIRECTED THERMODILUTION CATH is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1984-10-18 under 510(k) number K843409. 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 FLOW-DIRECTED THERMODILUTION CATH?

FLOW-DIRECTED THERMODILUTION CATH is a medical device that received FDA 510(k) clearance on 1984-10-18. The listed applicant is Andover Medical, Inc.. The 510(k) number is K843409.

When did FLOW-DIRECTED THERMODILUTION CATH receive FDA 510(k) clearance?

FLOW-DIRECTED THERMODILUTION CATH received FDA 510(k) clearance on 1984-10-18, under 510(k) number K843409.

Who is the listed applicant for FLOW-DIRECTED THERMODILUTION CATH?

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

What is the FDA product code for FLOW-DIRECTED THERMODILUTION CATH?

The FDA product code for FLOW-DIRECTED THERMODILUTION CATH 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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