Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath— 510(k) K142301

Substantially Equivalent

Cook Vascular, Inc.

FDA 510(k) clearance K142301 for Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath, Substantially Equivalent on 2014-11-12. Applicant: Cook Vascular, Inc..

Clearance details

Applicant: Cook Vascular, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2014-08-18
Decision date: 2014-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vandergrift, PA, US

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Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.