Swan-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)

About This 510(k) Submission

K233983 is an FDA 510(k) clearance for the Swan-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), a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on June 27, 2024, 192 days after receiving the submission on December 18, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.