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FDA 510(k)

SWAN GANZ CATHETER PLACEMENT KIT

K-Number: K802288 · 1980-11-20

ApplicantStanco Medical, Inc.
Decision Date1980-11-20
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN GANZ CATHETER PLACEMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Stanco Medical, Inc.. It received FDA 510(k) clearance on 1980-11-20 under 510(k) number K802288. 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 CATHETER PLACEMENT KIT?

SWAN GANZ CATHETER PLACEMENT KIT is a medical device that received FDA 510(k) clearance on 1980-11-20. The listed applicant is Stanco Medical, Inc.. The 510(k) number is K802288.

When did SWAN GANZ CATHETER PLACEMENT KIT receive FDA 510(k) clearance?

SWAN GANZ CATHETER PLACEMENT KIT received FDA 510(k) clearance on 1980-11-20, under 510(k) number K802288.

Who is the listed applicant for SWAN GANZ CATHETER PLACEMENT KIT?

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

What is the FDA product code for SWAN GANZ CATHETER PLACEMENT KIT?

The FDA product code for SWAN GANZ CATHETER PLACEMENT KIT is DYG.

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Other records listing Stanco Medical, Inc. 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.

K810643UNIVERSAL PACING ELECTRODE KITK810642ATRIAL-VENTRICULAR PACING ELECTRODE KITK802289PERICARDIOCENTESIS KITK802287RIGHT ATRIAL LINE KITK802259TRANSVENOUS PACEMAKER ELECTRODE KITK802290REGIONAL INTRAVENOUS ANESTHESIA KIT

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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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