ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD— 510(k) K011056

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K011056 for ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, Substantially Equivalent on 2001-10-24. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2001-04-06
Decision date: 2001-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, 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.