IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)— 510(k) K252827

Substantially Equivalent

Drägerwerk AG & Co. KGaA

FDA 510(k) clearance K252827 for IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559), Substantially Equivalent on 2025-12-01. Applicant: Drägerwerk AG & Co. KGaA.

Clearance details

Applicant: Drägerwerk AG & Co. KGaA
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2025-09-05
Decision date: 2025-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.