ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000— 510(k) K991060

Substantially Equivalent

Zcv ,Inc.

FDA 510(k) clearance K991060 for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000, Substantially Equivalent on 2000-04-06. Applicant: Zcv ,Inc..

Clearance details

Applicant: Zcv ,Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1999-03-30
Decision date: 2000-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.