Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set— 510(k) K162181

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K162181 for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set, Substantially Equivalent on 2017-01-06. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2016-08-04
Decision date: 2017-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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.