VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM— 510(k) K140169

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K140169 for VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM, Substantially Equivalent on 2014-05-21. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2014-01-23
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.