ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100— 510(k) K073631

Substantially Equivalent

Orqis Medical Corporation

FDA 510(k) clearance K073631 for ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100, Substantially Equivalent on 2008-06-27. Applicant: Orqis Medical Corporation.

Clearance details

Applicant: Orqis Medical Corporation
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2007-12-26
Decision date: 2008-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, 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.