IBP cable Becton Dickinson - IBP cable Abbott, Medex (2606490)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252827 FDA 510(k)
- FDA Product Code
- DSA FDA 510(k)
- Models / Variants
- IBP cable Abbott, Medex (2606490) FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2900 FDA 510(k)
- Regulation Number
- 870.2900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are Cable, Transducer and Electrode, Patient (Including Connector) designed for invasive blood pressure (IBP) monitoring. They facilitate the transmission of pressure signals from arterial catheters to monitoring systems, enabling real-time measurement of blood pressure within the cardiovascular system.
The cables are supplied sterile and intended for single-use, connecting arterial catheters to monitoring equipment such as those from Becton Dickinson, Edwards, Abbott/Medex, Utah, or Draeger systems. They are classified as Class II devices under FDA regulations (870.2900) and comply with MRI safety standards for use in clinical environments. Each variant (7-pin or 10-pin) is designed for specific manufacturer compatibility and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
Are these cables compatible with MRI environments, and if so, how should they be handled during scanning?
Yes, these IBP cables are designed with MRI safety standards in mind, allowing them to be used in clinical environments where MRI procedures are performed. However, they must be stored and handled according to the manufacturer’s instructions to ensure sterility and functionality. Since they are single-use, they should not be reused after exposure to an MRI or any other procedure, as this could compromise their integrity and safety.
How do I determine which cable variant is compatible with my existing monitoring equipment?
The compatibility of these cables depends on the manufacturer of your monitoring system. For example, the IBP cable Becton Dickinson (2606488) is designed for Becton Dickinson systems, while the IBP Adapter Cable Draeger 7-pin (2607558) is specifically for Draeger systems with a 7-pin interface. Always verify the pin configuration and manufacturer specifications before use to ensure proper connection and accurate blood pressure readings.
Are these cables reusable, or are they intended for single-use only?
These IBP cables are explicitly intended for single-use only. They are supplied sterile and should not be reused after a single procedure to maintain patient safety and prevent contamination. Reusing them could compromise sterility and potentially introduce infection risks.
What storage conditions should I follow to ensure the cables remain sterile and functional?
The cables must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since they are sterile upon packaging, they should remain in their sealed packaging until use. Avoid exposure to extreme temperatures, moisture, or physical damage, as these factors could compromise their integrity before use.
What regulatory pathways have these cables undergone, and how does that affect their use in clinical settings?
These cables have undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming they meet safety and performance standards for invasive blood pressure monitoring. The clearance indicates they are classified as Class II devices under FDA regulations (870.2900) and are intended for use in cardiovascular monitoring systems. Clinicians can rely on these regulatory pathways to ensure the cables are suitable for their intended purpose in clinical environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252827 | Class II | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA 510(k) K252827 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 18, 2026