CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER— 510(k) K993720

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K993720 for CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, Substantially Equivalent on 2000-01-18. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1999-11-03
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

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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.