K171146

Substantially Equivalent

Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.

Applicant: Arrow International, Inc. (Subsidiary of Telelflex Inc.)
Product code: DQY
Advisory panel: Cardiovascular
Date received: 2017-04-19
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.