DOCKING-EXTENSION WIRE— 510(k) K982592

Substantially Equivalent

Schneider (Europe) GmbH

FDA 510(k) clearance K982592 for DOCKING-EXTENSION WIRE, Substantially Equivalent on 1998-10-21. Applicant: Schneider (Europe) GmbH.

Clearance details

Applicant: Schneider (Europe) GmbH
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1998-07-24
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bulach, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.