K032375

Substantially Equivalent

VAXCEL PORT, MODELS 45-336 AND 45-338

Applicant: Boston Scientific Corp
Product code: LJT
Advisory panel: General Hospital
Date received: 2003-08-01
Decision date: 2003-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Glens Falls, NY, US

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.