6248VAL ADJUSTABLE VALVE— 510(k) K052459

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K052459 for 6248VAL ADJUSTABLE VALVE, Substantially Equivalent on 2006-01-11. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2005-09-07
Decision date: 2006-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.