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FDA 510(k)

CATHETER, CARDIOVASCULAR

K-Number: K771823 · 1977-12-20

ApplicantUsci, Div. C.R. Bard, Inc.
Decision Date1977-12-20
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, CARDIOVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Usci, Div. C.R. Bard, Inc.. It received FDA 510(k) clearance on 1977-12-20 under 510(k) number K771823. 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 CATHETER, CARDIOVASCULAR?

CATHETER, CARDIOVASCULAR is a medical device that received FDA 510(k) clearance on 1977-12-20. The listed applicant is Usci, Div. C.R. Bard, Inc.. The 510(k) number is K771823.

When did CATHETER, CARDIOVASCULAR receive FDA 510(k) clearance?

CATHETER, CARDIOVASCULAR received FDA 510(k) clearance on 1977-12-20, under 510(k) number K771823.

Who is the listed applicant for CATHETER, CARDIOVASCULAR?

The FDA 510(k) record lists Usci, Div. C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER, CARDIOVASCULAR?

The FDA product code for CATHETER, CARDIOVASCULAR is DYG.

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Other records listing Usci, Div. C.R. Bard, 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.

K940092USCI INPUT INTRODUCER SETK884209USCI DORROS INFUSION/PROBING CATHETERK772021TRC STAINLESS STEEL SAFETY SPRING GUIDESK771982888 ARTERIAL/VENOUS CATHETER INTRODUCERK770835PATCH FABRICK770561CATHETER,PERCUTANEOUS INTRODUC. & SHEATH

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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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