Straub Endovascular System— 510(k) K172315

Substantially Equivalent

Straub Medical AG

FDA 510(k) clearance K172315 for Straub Endovascular System, Substantially Equivalent on 2018-04-12. Applicant: Straub Medical AG.

Clearance details

Applicant: Straub Medical AG
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2017-08-01
Decision date: 2018-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wangs, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.