Amplatz Support Wire Guide with Apex Curve— 510(k) K171445

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K171445 for Amplatz Support Wire Guide with Apex Curve, Substantially Equivalent on 2018-01-10. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2017-05-16
Decision date: 2018-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.