Home / 510(k) Clearances / K240078

510(k) K240078

Fogarty Thru-Lumen Embolectomy Catheter by Edwards Lifesciences, LLC — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2024
Date Received
January 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Edwards Lifesciences, LLC

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253034 — HemoSphere Stream Module (October 21, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K252364 — Edwards eSheath Optima introducer set (August 29, 2025)
  • K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); Hem (July 23, 2025)
  • K242518 — Hypertension Prediction Index (HePI) Algorithm (May 15, 2025)
  • K244046 — Edwards eSheath Optima introducer set (March 27, 2025)
  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)

Other clearances for product code DXE

  • K241330 — Fogarty Fortis Arterial Embolectomy Catheter (July 2, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (May 22, 2024)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K213771 — Merlin Aspiration System (January 27, 2022)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)
  • K152335 — Export Advance Aspiration Catheter (September 18, 2015)