Cleared Traditional

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

K231248 · Edwards Lifesciencess, LLC · Cardiovascular

Sep 2023

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K231248 is an FDA 510(k) clearance for the Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform, a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Edwards Lifesciencess, LLC (Irvine, US). The FDA issued a Cleared decision on September 21, 2023, 143 days after receiving the submission on May 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number	K231248 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2023
Decision Date	September 21, 2023
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF