VAXCEL WITH PASV PORT, MODEL 45-213— 510(k) K032008

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K032008 for VAXCEL WITH PASV PORT, MODEL 45-213, Substantially Equivalent on 2003-07-14. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2003-06-30
Decision date: 2003-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

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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.