LMI THROMBECTOMY CATHETER— 510(k) K970657

Name: FDA 510(k) clearance K970657
Creator: U.S. Food and Drug Administration
Published: 1997-07-01

Substantially Equivalent

Lucas Medical, Inc.

FDA 510(k) clearance K970657 for LMI THROMBECTOMY CATHETER, Substantially Equivalent on 1997-07-01. 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: 1997-02-21
Decision date: 1997-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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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.