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FDA 510(k)

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

K-Number: K802481 · 1980-10-31

ApplicantWaters Assoc., Inc.
Decision Date1980-10-31
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH is the device name listed in this FDA 510(k) record. The listed applicant is Waters Assoc., Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802481. 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 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH?

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K802481.

When did 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH receive FDA 510(k) clearance?

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802481.

Who is the listed applicant for 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH?

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

What is the FDA product code for 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH?

The FDA product code for 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH is DYG.

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Other records listing Waters Assoc., 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.

K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOLK801852MRM-2 OXYGEN CONSUMPTION MONITORK801431PAN-AM MYELOGRAM TRAYK791661SYSTEM CONTROLLER 720 SERIESK7910264F STERILE BALLOON-LESS, CATHETER 913-28K782175CARTRIDGE HOLDER, RCM 100

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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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