MEDTRONIC EXPORT AP CATHETER— 510(k) K081573

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K081573 for MEDTRONIC EXPORT AP CATHETER, Substantially Equivalent on 2008-06-27. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 2008-06-05
Decision date: 2008-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.