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FDA 510(k)

CORDIS FLOW DIRECTED BALLOON CATHETER

K-Number: K801865 · 1980-08-20

ApplicantCordis Corp.
Decision Date1980-08-20
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS FLOW DIRECTED BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801865. 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 CORDIS FLOW DIRECTED BALLOON CATHETER?

CORDIS FLOW DIRECTED BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Cordis Corp.. The 510(k) number is K801865.

When did CORDIS FLOW DIRECTED BALLOON CATHETER receive FDA 510(k) clearance?

CORDIS FLOW DIRECTED BALLOON CATHETER received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801865.

Who is the listed applicant for CORDIS FLOW DIRECTED BALLOON CATHETER?

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

What is the FDA product code for CORDIS FLOW DIRECTED BALLOON CATHETER?

The FDA product code for CORDIS FLOW DIRECTED BALLOON CATHETER is DYG.

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Other records listing Cordis Corp. 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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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