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FDA 510(k)

CATHETER, PACING/MONITORING

K-Number: K772059 · 1977-11-15

ApplicantElectro-Catheter Corp.
Decision Date1977-11-15
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, PACING/MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K772059. 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, PACING/MONITORING?

CATHETER, PACING/MONITORING is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K772059.

When did CATHETER, PACING/MONITORING receive FDA 510(k) clearance?

CATHETER, PACING/MONITORING received FDA 510(k) clearance on 1977-11-15, under 510(k) number K772059.

Who is the listed applicant for CATHETER, PACING/MONITORING?

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

What is the FDA product code for CATHETER, PACING/MONITORING?

The FDA product code for CATHETER, PACING/MONITORING is DYG.

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Other records listing Electro-Catheter 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.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING 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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