LMI ARTERIAL EMBOLECTOMY CATHETER— 510(k) K954760

Name: FDA 510(k) clearance K954760
Creator: U.S. Food and Drug Administration
Published: 1996-04-11

Substantially Equivalent

Lucas Medical, Inc.

FDA 510(k) clearance K954760 for LMI ARTERIAL EMBOLECTOMY CATHETER, Substantially Equivalent on 1996-04-11. Applicant: Lucas Medical, Inc.. Device class: 2.

Clearance details

Applicant: Lucas Medical, Inc.
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 1995-10-17
Decision date: 1996-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXE

view all

K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
K233819 — Fogarty Venous Thrombectomy Catheters2024-05-22
K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

More clearances from Lucas Medical, Inc.

view all

K983802 — LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB1999-07-30
K972623 — LMI IRRIGATION CATHETER (IGR)1997-11-19
K970657 — LMI THROMBECTOMY CATHETER1997-07-01
K955126 — LMI BILIARY CATHETER1996-05-10
K955125 — LMI OCCLUSION CATHETER1996-03-11

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.