Mini Balloon

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Device, Vascular, for Promoting Embolization

PMA Number

P780011 ↗

FDA Product Code

KRD

Device Class

Class II

Regulation

21 CFR Part 870.3300

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S003

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• What types of medical procedures is the Mini Balloon designed to assist with, and why is it specifically mounted on a catheter?

  The Mini Balloon is designed to occlude blood vessels during interventional radiology and cardiology procedures, particularly to block abnormal blood flow in conditions like arteriovenous malformations or vascular tumors. Its catheter-mounted design allows for precise deployment within targeted vessels, enabling controlled inflation to effectively seal off the vessel while minimizing trauma to surrounding tissues.

• Is the Mini Balloon intended for reuse, or is it meant to be used only once per patient? How does this affect its sterility?

  The Mini Balloon is explicitly supplied as a single-use device, meaning it is intended for one-time use per patient. This design ensures sterility is maintained throughout its intended use, as it is packaged sterile and not intended for reprocessing or reuse, which could compromise its safety and effectiveness.

• Can the Mini Balloon be used in MRI environments, and if so, what considerations should clinicians keep in mind?

  Yes, the Mini Balloon is approved for use in MRI environments, but its compatibility must be confirmed with the specific imaging system being used. Clinicians should verify that the balloon’s materials and construction do not interfere with the MRI’s magnetic field or imaging quality, ensuring safe and accurate deployment during the procedure.

• What regulatory pathway was followed for the Mini Balloon’s approval, and what does this mean for its clinical use?

  The Mini Balloon received FDA approval through the Premarket Approval (PMA) pathway, indicated by PMA number P780011. This means the device underwent rigorous clinical testing and review to demonstrate safety and effectiveness for its intended use in occluding blood vessels, ensuring it meets stringent regulatory standards before clinical deployment.