CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER— 510(k) K023880

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K023880 for CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER, Substantially Equivalent on 2002-12-11. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2002-11-21
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, NJ, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.