K161313

Substantially Equivalent

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Product code: PND
Advisory panel: General Hospital
Date received: 2016-05-10
Decision date: 2016-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.