CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER— 510(k) K023907

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K023907 for CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER, Substantially Equivalent on 2002-12-18. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2002-11-25
Decision date: 2002-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Warren, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.