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FDA 510(k)

MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER

K-Number: K883948 · 1989-04-21

ApplicantNuMED, Inc.
Decision Date1989-04-21
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K883948. 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 MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER?

MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is NuMED, Inc.. The 510(k) number is K883948.

When did MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1989-04-21, under 510(k) number K883948.

Who is the listed applicant for MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER?

The FDA product code for MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER 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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