Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)

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

510(k) Number

K964021 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Baxter Edwards →

• What is the Intramed SBO System (700095/700099) used for?

  The Intramed Side Branch Occlusion (SBO) System is designed specifically for neurovascular embolization procedures. It blocks unwanted blood flow in cerebral arteries, such as those supplying arteriovenous malformations or aneurysms, to reduce perfusion to targeted vascular abnormalities. This supports therapeutic interventions in neurology by isolating problematic vessels during interventional neuroradiology.

• How is the Intramed SBO System supplied and what are its sterility and reuse details?

  The Intramed SBO System is supplied as a sterile, single-use device. Each kit is individually packaged to maintain sterility and is not intended for reuse. Adherence to sterile medical device protocols during storage and handling is critical to preserve its integrity and functionality for clinical use.

• Does the system include a catheter, and what are its key features?

  Yes, the system includes an introducer catheter with a composite shaft featuring two lumens. This design facilitates precise delivery of occlusion coils to the targeted side branches in cerebral arteries, ensuring effective embolization during procedures.

• Can the Intramed SBO System be used in MRI environments?

  The Intramed SBO System is explicitly designed for use in MRI-safe environments. This ensures compatibility with magnetic resonance imaging equipment, reducing the risk of interference or safety concerns during neurovascular procedures.

• What regulatory pathway does this device follow, and what class is it assigned?

  The Intramed SBO System follows the FDA 510(k) clearance pathway and is classified as a Class II device under the HCG product code. It was granted clearance in 1997 under the decision code SESE (Substantially Equivalent) by Baxter Edwards, with the advisory committee designation for Neurology (NE).