REBOA Balloon Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by NuMED, Inc.
Identifiers
- 510(k) Number
- K160598 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The REBOA Balloon Catheter is an intravascular occluding device designed for temporary vascular occlusion. Classified as a catheter under the nomenclature authority, it is intended for selective occlusion of major blood vessels to control hemorrhage in critical trauma or surgical settings, particularly in the abdominal aorta or its branches.
This single-use device is supplied sterile and is regulated under FDA 510(k) clearance (K160598) and the Medical Device Directive (MDD). It is intended for use in emergency procedures, with sizes and configurations listed in the OpenFDA registration (e.g., FEI numbers provided). The device must be handled in accordance with sterile field protocols and is not reusable. MRI safety is not specified, and storage conditions align with standard sterile catheter requirements.
Frequently asked questions
What is the primary clinical use for the REBOA Balloon Catheter, and in which emergency settings is it typically deployed?
The REBOA Balloon Catheter is designed for temporary vascular occlusion to control severe hemorrhage in critical trauma or surgical scenarios. It is specifically intended for selective occlusion of major blood vessels, such as the abdominal aorta or its branches, to stabilize patients during life-threatening bleeding events. This device is primarily used in emergency procedures where rapid hemorrhage control is essential, such as in trauma resuscitation or high-risk surgical interventions.
How is the REBOA Balloon Catheter supplied, and what should clinicians consider regarding its sterility and single-use nature?
The REBOA Balloon Catheter is supplied sterile and is intended for single-use only. Clinicians must adhere to sterile field protocols when handling the device to prevent contamination. Since it is not reusable, each catheter must be discarded after a single procedure to ensure patient safety and maintain sterility.
Are there multiple sizes or models available for the REBOA Balloon Catheter, and how can I verify the specific configurations?
Yes, the REBOA Balloon Catheter comes in multiple sizes and configurations, as indicated by the various FEI numbers listed in the OpenFDA registration (e.g., 1721676, 3026788751, etc.). These FEI numbers correspond to different product codes and models, allowing for selection based on the patient’s anatomy and clinical needs. For precise details on sizing, refer to the manufacturer’s documentation or the OpenFDA database.
What storage conditions should be followed for the REBOA Balloon Catheter to ensure its integrity before use?
The REBOA Balloon Catheter should be stored under conditions consistent with standard sterile catheter requirements. This typically includes maintaining a clean, dry environment, protecting it from physical damage, and ensuring it remains within its expiration date. Always follow the manufacturer’s guidelines for storage to preserve sterility and functionality.
What regulatory pathways have been followed for the REBOA Balloon Catheter, and how does this affect its availability?
The REBOA Balloon Catheter has undergone FDA 510(k) clearance (K160598) and complies with the Medical Device Directive (MDD). These regulatory pathways confirm that the device meets established safety and performance standards for its intended use as an intravascular occluding catheter. Availability is supported by these clearances, ensuring it can be legally marketed and used in clinical settings where hemorrhage control is critical.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160598 | Class II | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
Sources (2)
- FDA 510(k) K160598 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026