OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER— 510(k) K091077

Substantially Equivalent

Cordis Corp., A Johnson & Johnson Co.

FDA 510(k) clearance K091077 for OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER, Substantially Equivalent on 2010-02-04. Applicant: Cordis Corp., A Johnson & Johnson Co..

Clearance details

Applicant: Cordis Corp., A Johnson & Johnson Co.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2009-04-14
Decision date: 2010-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Bridgewater, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.