PW Guidewires— 510(k) K152497

Substantially Equivalent

Tatara Vascular, LLC

FDA 510(k) clearance K152497 for PW Guidewires, Substantially Equivalent on 2016-01-22. Applicant: Tatara Vascular, LLC.

Clearance details

Applicant: Tatara Vascular, LLC
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2015-09-01
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.