OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120— 510(k) K083814

Substantially Equivalent

Cordis Corp., A Johnson & Johnson Co.

FDA 510(k) clearance K083814 for OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120, Substantially Equivalent on 2009-01-13. Applicant: Cordis Corp., A Johnson & Johnson Co..

Clearance details

Applicant: Cordis Corp., A Johnson & Johnson Co.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2008-12-22
Decision date: 2009-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warren, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.