K091261

Substantially Equivalent

NMI PICC

Applicant: Navilyst Medical, Inc.
Product code: LJS
Advisory panel: General Hospital
Date received: 2009-04-29
Decision date: 2009-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, US

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.