CENTRAL VENOUS CATHETER— 510(k) K003839

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K003839 for CENTRAL VENOUS CATHETER, Substantially Equivalent on 2001-08-01. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2000-12-12
Decision date: 2001-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

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.