K163353

Substantially Equivalent

Needle's Eye Snare Retrieval Set - 54cm

Applicant: Cook Incorporated
Product code: DXE
Advisory panel: Cardiovascular
Date received: 2016-11-30
Decision date: 2017-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.