Wattson temporary pacing guidewire (2250)— 510(k) K230637

Substantially Equivalent

Vascular Solutions, LLC

FDA 510(k) clearance K230637 for Wattson temporary pacing guidewire (2250), Substantially Equivalent on 2023-05-05. Applicant: Vascular Solutions, LLC.

Clearance details

Applicant: Vascular Solutions, LLC
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2023-03-07
Decision date: 2023-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.