MEDIVALVE ACWIRE— 510(k) K132545

Substantially Equivalent

Medivalve , Ltd.

FDA 510(k) clearance K132545 for MEDIVALVE ACWIRE, Substantially Equivalent on 2013-11-08. Applicant: Medivalve , Ltd..

Clearance details

Applicant: Medivalve , Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2013-08-13
Decision date: 2013-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.