OUTBACK Elite Re-Entry Catheter— 510(k) K150836

Substantially Equivalent

Cordis Corporation, A Johnson & Johnson Co.

FDA 510(k) clearance K150836 for OUTBACK Elite Re-Entry Catheter, Substantially Equivalent on 2015-04-29. Applicant: Cordis Corporation, A Johnson & Johnson Co..

Clearance details

Applicant: Cordis Corporation, A Johnson & Johnson Co.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2015-03-30
Decision date: 2015-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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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.