HQS Introducer (Model 2064-HQS)— 510(k) K153494

Substantially Equivalent

Alseal

FDA 510(k) clearance K153494 for HQS Introducer (Model 2064-HQS), Substantially Equivalent on 2016-08-25. Applicant: Alseal.

Clearance details

Applicant: Alseal
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2015-12-04
Decision date: 2016-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besancon, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.