Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter— 510(k) K150046

Unknown

Zoll Circulation, Inc.

FDA 510(k) clearance K150046 for Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Unknown on 2015-10-30. Applicant: Zoll Circulation, Inc..

Clearance details

Applicant: Zoll Circulation, Inc.
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2015-01-12
Decision date: 2015-10-30
Decision: Unknown
Clearance type: Traditional
Location: San Jose, CA, US

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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.