Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC

• • Terminated Z-0845-2011 FDA Unclassified (pre-2012) ·initiated 21 Oct 2010

  The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.

510(k) Number

K072173 ↗

FDA Product Code

HCG

Models / Variants

Micrus Microcoil System Cashmere-Cerecyte, Model Crc

Cashmere-Sr, Model Src

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 Micrus Endovascular Corporation →

• What are the Micrus Cashmere-Cerecyte and Cashmere-SR coils designed for?

  These coils are designed specifically for endovascular treatment of intracranial aneurysms. They work by occluding blood flow within the aneurysm sac, encouraging thrombosis and reducing the risk of rupture. The precise engineering of the Cashmere-Cerecyte (Model CRC) and Cashmere-SR (Model SRC) models ensures accurate deployment during neurovascular procedures.

• How are the Micrus Microcoil System Cashmere-Cerecyte and Cashmere-SR supplied?

  The system is supplied as a sterile, single-use device. It is intended for professional medical personnel to deploy via microcatheters in interventional radiology or neurosurgery settings. Each coil is packaged individually to maintain sterility until use.

• Are these coils MRI-safe?

  No, the Micrus Microcoil System Cashmere-Cerecyte and Cashmere-SR coils are not MRI-safe. They must be used with compatible imaging equipment to avoid interference or safety risks during procedures.

• What storage conditions should be followed for these coils?

  While specific storage instructions are not detailed in the provided data, neurovascular embolization coils generally require protection from moisture and extreme temperatures. Store in a dry, sealed environment away from direct sunlight or heat sources to preserve sterility and integrity.

• What regulatory clearance does the Micrus Microcoil System hold?

  The device holds an FDA 510(k) clearance (K072173) under substantial equivalence to predicate devices. This clearance confirms regulatory compliance for use in the United States as a neurovascular embolization coil for intracranial aneurysm treatment.