KAVS - CATHETER, MODELS 1107100 & 1107060— 510(k) K052844

Substantially Equivalent

Richter & Rothe AG

FDA 510(k) clearance K052844 for KAVS - CATHETER, MODELS 1107100 & 1107060, Substantially Equivalent on 2006-03-20. Applicant: Richter & Rothe AG.

Clearance details

Applicant: Richter & Rothe AG
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2005-10-07
Decision date: 2006-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leipzig, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.