Amecath Peripheral inserted Central Venous Catheter Sets— 510(k) K152819

Substantially Equivalent

Ameco Medical Industries

FDA 510(k) clearance K152819 for Amecath Peripheral inserted Central Venous Catheter Sets, Substantially Equivalent on 2016-02-05. Applicant: Ameco Medical Industries.

Clearance details

Applicant: Ameco Medical Industries
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2015-09-28
Decision date: 2016-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 10th Of Ramadan City, EG

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.