ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520— 510(k) K093050

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K093050 for ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520, Substantially Equivalent on 2009-12-18. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2009-09-30
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

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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.