510(k) K011761— MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

Substantially Equivalent

Arrow Intl., Inc.

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2001-06-06
Decision date: 2001-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.