CLAVIS— 510(k) K062478

Substantially Equivalent

Medtronic A/S

FDA 510(k) clearance K062478 for CLAVIS, Substantially Equivalent on 2007-02-08. Applicant: Medtronic A/S.

Clearance details

Applicant: Medtronic A/S
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 2006-08-24
Decision date: 2007-02-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skovlunde, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

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.