SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF— 510(k) K912604

Substantially Equivalent

Aries Medical, Inc.

FDA 510(k) clearance K912604 for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF, Substantially Equivalent on 1991-10-28. Applicant: Aries Medical, Inc..

Clearance details

Applicant: Aries Medical, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1991-05-31
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

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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.