samaritan PAD 450P— 510(k) K142709

Substantially Equivalent

Heartsine Technologies, Inc.

FDA 510(k) clearance K142709 for samaritan PAD 450P, Substantially Equivalent on 2015-03-27. Applicant: Heartsine Technologies, Inc..

Clearance details

Applicant: Heartsine Technologies, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2014-09-22
Decision date: 2015-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.