In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath— 510(k) K201165

Unknown

Coloplast Corp.

FDA 510(k) clearance K201165 for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath, Unknown on 2020-12-17. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code LJE
Advisory panel: Unknown
Date received: 2020-05-01
Decision date: 2020-12-17
Decision: Unknown
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.