CG+ ARROW JACC POWERED BY ARROW VPS STYLET— 510(k) K132133

Substantially Equivalent

Arrow International (Subsidiary of Teleflex Inc.)

FDA 510(k) clearance K132133 for CG+ ARROW JACC POWERED BY ARROW VPS STYLET, Substantially Equivalent on 2013-09-26. Applicant: Arrow International (Subsidiary of Teleflex Inc.).

Clearance details

Applicant: Arrow International (Subsidiary of Teleflex Inc.)
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2013-07-11
Decision date: 2013-09-26
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.