Clearance Summary
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) received FDA 510(k) clearance under submission number K233983, sponsored by Edwards Lifesciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-06-27.
- Submission: K233983
- Applicant / Sponsor: Edwards Lifesciences
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 2024-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.