ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS— 510(k) K141618

Substantially Equivalent

Arrow International, Inc (Subsidiary of Teleflex I

FDA 510(k) clearance K141618 for ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS, Substantially Equivalent on 2014-07-08. Applicant: Arrow International, Inc (Subsidiary of Teleflex I.

Clearance details

Applicant: Arrow International, Inc (Subsidiary of Teleflex I
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2014-06-17
Decision date: 2014-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.