LOFRIC(R), LOFRIC(R) CATH-KIT— 510(k) K896750

Substantially Equivalent

Astra Meditec AB

FDA 510(k) clearance K896750 for LOFRIC(R), LOFRIC(R) CATH-KIT, Substantially Equivalent on 1990-08-06. Applicant: Astra Meditec AB.

Clearance details

Applicant: Astra Meditec AB
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-30
Decision date: 1990-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

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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.