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FDA 510(k)

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER

K-Number: K940795 · 1994-05-24

ApplicantBaxter Edwards
Decision Date1994-05-24
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1994-05-24 under 510(k) number K940795. 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 CC0/SVO2 THERMODILUTION CATHETER?

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1994-05-24. The listed applicant is Baxter Edwards. The 510(k) number is K940795.

When did SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER receive FDA 510(k) clearance?

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER received FDA 510(k) clearance on 1994-05-24, under 510(k) number K940795.

Who is the listed applicant for SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER?

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

What is the FDA product code for SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER?

The FDA product code for SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER is DYG.

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Other records listing Baxter Edwards 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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

View all 11 devices →

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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