L-CATH CATHETER SYSTEM - PORT L-CATH— 510(k) K942103

Substantially Equivalent

Luther Medical Products, Inc.

FDA 510(k) clearance K942103 for L-CATH CATHETER SYSTEM - PORT L-CATH, Substantially Equivalent on 1994-07-26. Applicant: Luther Medical Products, Inc..

Clearance details

Applicant: Luther Medical Products, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1994-05-02
Decision date: 1994-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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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.