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FDA 510(k)

SWAN-GANZ BIPOLAR PACING CATHETER

K-Number: K822723 · 1982-10-15

ApplicantAmerican Edwards Laboratories
Decision Date1982-10-15
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ BIPOLAR PACING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1982-10-15 under 510(k) number K822723. 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 SWAN-GANZ BIPOLAR PACING CATHETER?

SWAN-GANZ BIPOLAR PACING CATHETER is a medical device that received FDA 510(k) clearance on 1982-10-15. The listed applicant is American Edwards Laboratories. The 510(k) number is K822723.

When did SWAN-GANZ BIPOLAR PACING CATHETER receive FDA 510(k) clearance?

SWAN-GANZ BIPOLAR PACING CATHETER received FDA 510(k) clearance on 1982-10-15, under 510(k) number K822723.

Who is the listed applicant for SWAN-GANZ BIPOLAR PACING CATHETER?

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

What is the FDA product code for SWAN-GANZ BIPOLAR PACING CATHETER?

The FDA product code for SWAN-GANZ BIPOLAR PACING CATHETER is DYG.

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Other records listing American Edwards Laboratories as applicant

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K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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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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