IBP cable Becton Dickinson (2606488) +5 more— 510(k) K252827

Substantially Equivalent

Drägerwerk AG & Co. KGaA

FDA 510(k) clearance K252827 for IBP cable Becton Dickinson (2606488) +5 more, Substantially Equivalent on 2025-12-01. Applicant: Drägerwerk AG & Co. KGaA. Device class: 2.

Clearance details

Device name as filed
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)
Applicant
Drägerwerk AG & Co. KGaA
Product code
Code DSA
Device class
Class 2
Regulation
21 CFR 870.2900
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Luebeck, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSA

product code DSA
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.