ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE— 510(k) K011847

Name: FDA 510(k) clearance K011847
Creator: U.S. Food and Drug Administration
Published: 2001-07-13

Substantially Equivalent

Zynergy Cardio Vasular (Zcv), Inc.

FDA 510(k) clearance K011847 for ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE, Substantially Equivalent on 2001-07-13. Applicant: Zynergy Cardio Vasular (Zcv), Inc.. Device class: 2.

Clearance details

Applicant: Zynergy Cardio Vasular (Zcv), Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 2001-06-13
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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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.