Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0— 510(k) K003118

Substantially Equivalent

Zcv ,Inc.

FDA 510(k) clearance K003118 for Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0, Substantially Equivalent on 2000-12-20. Applicant: Zcv ,Inc..

Clearance details

Applicant: Zcv ,Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 2000-10-05
Decision date: 2000-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.