COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593— 510(k) K101987

Unknown

Zoll Circulation

FDA 510(k) clearance K101987 for COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593, Unknown on 2010-10-12. Applicant: Zoll Circulation.

Clearance details

Applicant: Zoll Circulation
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2010-07-14
Decision date: 2010-10-12
Decision: Unknown
Clearance type: Traditional
Location: Sunnyvale, 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.