ACCU-CHEK ULTRAFLEX INFUSION SET— 510(k) K070189

Substantially Equivalent

Disetronic Medical Systems AG

FDA 510(k) clearance K070189 for ACCU-CHEK ULTRAFLEX INFUSION SET, Substantially Equivalent on 2007-02-21. Applicant: Disetronic Medical Systems AG.

Clearance details

Applicant: Disetronic Medical Systems AG
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2007-01-22
Decision date: 2007-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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.