LMT-KATH-S; LMT-KATH-I— 510(k) K062308

Substantially Equivalent

Licher Medizintechnologie GmbH

FDA 510(k) clearance K062308 for LMT-KATH-S; LMT-KATH-I, Substantially Equivalent on 2007-03-20. Applicant: Licher Medizintechnologie GmbH.

Clearance details

Applicant: Licher Medizintechnologie GmbH
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2006-08-08
Decision date: 2007-03-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wedemark, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.