SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER— 510(k) K141139

Substantially Equivalent

Zoll Circulation

FDA 510(k) clearance K141139 for SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER, Substantially Equivalent on 2014-10-03. Applicant: Zoll Circulation.

Clearance details

Applicant: Zoll Circulation
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2014-05-02
Decision date: 2014-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NCX

product code NCX

Death: 30
Malfunction: 2,302
Total: 2,332

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.