LAKE CATHETER CARE KITS (MODIFICATION)— 510(k) K875383

Unknown

Lake Medical Products, Inc.

FDA 510(k) clearance K875383 for LAKE CATHETER CARE KITS (MODIFICATION), Unknown on 1988-03-09. Applicant: Lake Medical Products, Inc..

Clearance details

Applicant: Lake Medical Products, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1987-12-15
Decision date: 1988-03-09
Decision: Unknown
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.