K962849

Substantially Equivalent

CATHETER INSERTION TRAY

Applicant: Medcare Medical Group, Inc.
Product code: LJS
Advisory panel: General Hospital
Date received: 1996-07-22
Decision date: 1996-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Swanzey, NH, 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.