STEALTH 360 ORBITAL PAD SYSTEM— 510(k) K131092

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K131092 for STEALTH 360 ORBITAL PAD SYSTEM, Substantially Equivalent on 2013-06-24. Applicant: Cardio Systems, Inc..

Clearance details

Applicant: Cardio Systems, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2013-04-18
Decision date: 2013-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.