MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER— 510(k) K050542

Substantially Equivalent

Marian Medical, Inc.

FDA 510(k) clearance K050542 for MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER, Substantially Equivalent on 2005-07-26. Applicant: Marian Medical, Inc..

Clearance details

Applicant: Marian Medical, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2005-03-02
Decision date: 2005-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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.