ROTAFLOW CENTRIFUGAL PUMP SYSTEM— 510(k) K991864

Substantially Equivalent

Jostra Medizintechnik AG

FDA 510(k) clearance K991864 for ROTAFLOW CENTRIFUGAL PUMP SYSTEM, Substantially Equivalent on 2000-08-31. Applicant: Jostra Medizintechnik AG.

Clearance details

Applicant: Jostra Medizintechnik AG
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1999-06-01
Decision date: 2000-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.