NMI PORT II CATHETER— 510(k) K131694

Substantially Equivalent

Navilyst Medical, Inc.

FDA 510(k) clearance K131694 for NMI PORT II CATHETER, Substantially Equivalent on 2013-08-08. Applicant: Navilyst Medical, Inc..

Clearance details

Applicant: Navilyst Medical, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2013-06-10
Decision date: 2013-08-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlborough, MA, 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.