Pounce Thrombus Retrieval System— 510(k) K192814

Substantially Equivalent

Surmodics,Inc.

FDA 510(k) clearance K192814 for Pounce Thrombus Retrieval System, Substantially Equivalent on 2020-09-21. Applicant: Surmodics,Inc..

Clearance details

Applicant: Surmodics,Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2019-10-01
Decision date: 2020-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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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.