K002481

Substantially Equivalent

ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3

Applicant: Zcv ,Inc.
Product code: LDF
Advisory panel: Cardiovascular
Date received: 2000-08-14
Decision date: 2000-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.