ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3— 510(k) K002687

Substantially Equivalent

Zynergy Cardiovascular, Inc.

FDA 510(k) clearance K002687 for ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3, Substantially Equivalent on 2000-11-09. Applicant: Zynergy Cardiovascular, Inc..

Clearance details

Applicant: Zynergy Cardiovascular, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 2000-08-29
Decision date: 2000-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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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.