ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)— 510(k) K121501

Substantially Equivalent

Arrow International (Subsidiary of Teleflex Inc.)

FDA 510(k) clearance K121501 for ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC), Substantially Equivalent on 2012-11-29. Applicant: Arrow International (Subsidiary of Teleflex Inc.).

Clearance details

Applicant: Arrow International (Subsidiary of Teleflex Inc.)
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2012-05-21
Decision date: 2012-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.