SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)— 510(k) K915363

Substantially Equivalent

3M Health Care, Ltd.

FDA 510(k) clearance K915363 for SARNS 7850 CENTRIFUGAL PUMP (MODIFIED), Substantially Equivalent on 1993-07-28. Applicant: 3M Health Care, Ltd..

Clearance details

Applicant: 3M Health Care, Ltd.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1991-11-27
Decision date: 1993-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, 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.