MCKESSON CARDIOLOGY HEMO— 510(k) K131497

Substantially Equivalent

Mckesson Israel , Ltd.

FDA 510(k) clearance K131497 for MCKESSON CARDIOLOGY HEMO, Substantially Equivalent on 2013-12-05. Applicant: Mckesson Israel , Ltd..

Clearance details

Applicant: Mckesson Israel , Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2013-05-24
Decision date: 2013-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.