PULTOL— 510(k) K113865

Substantially Equivalent

Sharp Corporation

FDA 510(k) clearance K113865 for PULTOL, Substantially Equivalent on 2012-03-21. Applicant: Sharp Corporation.

Clearance details

Applicant: Sharp Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2011-12-30
Decision date: 2012-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.