ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488— 510(k) K063210

Substantially Equivalent

Medtronic Inc. Cardiac Rhythm Management

FDA 510(k) clearance K063210 for ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488, Substantially Equivalent on 2007-03-15. Applicant: Medtronic Inc. Cardiac Rhythm Management.

Clearance details

Applicant: Medtronic Inc. Cardiac Rhythm Management
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2006-10-23
Decision date: 2007-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, US

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.