Accu-Chek FlexLink Plus infusion set— 510(k) K143446

Substantially Equivalent

Roche Diagnostics GmbH

FDA 510(k) clearance K143446 for Accu-Chek FlexLink Plus infusion set, Substantially Equivalent on 2015-08-13. Applicant: Roche Diagnostics GmbH.

Clearance details

Applicant: Roche Diagnostics GmbH
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2014-12-02
Decision date: 2015-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mannheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.