ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)— 510(k) K980090

Substantially Equivalent

Luther Medical Products, Inc.

FDA 510(k) clearance K980090 for ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM), Substantially Equivalent on 1998-03-24. Applicant: Luther Medical Products, Inc..

Clearance details

Applicant: Luther Medical Products, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1998-01-09
Decision date: 1998-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

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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.