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FDA 510(k)

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES

K-Number: K901247 · 1990-07-31

ApplicantIntec Medical, Inc.
Decision Date1990-07-31
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K901247. 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 TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES?

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Intec Medical, Inc.. The 510(k) number is K901247.

When did TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES receive FDA 510(k) clearance?

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES received FDA 510(k) clearance on 1990-07-31, under 510(k) number K901247.

Who is the listed applicant for TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES?

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

What is the FDA product code for TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES?

The FDA product code for TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES 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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