Pounce XL Thrombectomy System (PTS-1011-7F135)— 510(k) K241362

Substantially Equivalent

Surmodics,Inc.

FDA 510(k) clearance K241362 for Pounce XL Thrombectomy System (PTS-1011-7F135), Substantially Equivalent on 2024-09-11. Applicant: Surmodics,Inc..

Clearance details

Applicant: Surmodics,Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2024-05-14
Decision date: 2024-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.