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FDA 510(k)

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform

K-Number: K231248 · 2023-09-21

ApplicantEdwards Lifesciencess, LLC
Decision Date2023-09-21
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is a medical device manufactured by Edwards Lifesciencess, LLC. It received FDA 510(k) clearance on 2023-09-21 under approval number K231248. 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 Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2023-09-21. It is manufactured by Edwards Lifesciencess, LLC. The 510(k) number is K231248.

When was Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform approved by the FDA?

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2023-09-21, under approval number K231248.

What company makes Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is manufactured by Edwards Lifesciencess, LLC.

What is the FDA product code for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform?

The FDA product code for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform is DYG.

Related Clinical Trials

NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT06148571 Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal RECRUITING NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING

Related PubMed Literature

PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

Related Devices (Code: DYG)

K160084Swan Ganz CathetersEdwards Lifesciences, LLC K193466Swan-Ganz CathetersEdwards Lifesciences, LLC K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards Lifesciences K233983Swan-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 Lifesciences K233824Swan-Ganz catheterEdwards Lifesciences, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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