POLYSITE IMPLANTABLE INFUSION PORTS— 510(k) K122834

Substantially Equivalent

Perouse Medical

FDA 510(k) clearance K122834 for POLYSITE IMPLANTABLE INFUSION PORTS, Substantially Equivalent on 2013-12-11. Applicant: Perouse Medical.

Clearance details

Applicant: Perouse Medical
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2012-09-17
Decision date: 2013-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: France, FR

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.