AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER

K024349 · Aesculap, Inc. · HCH · Mar 24, 2003 · Neurology

Device Facts

• Record ID: K024349
• Device Name: AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
• Applicant: Aesculap, Inc.
• Product Code: HCH · Neurology
• Decision Date: Mar 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels. The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.

Device Story

Aesculap AVM Microclips and Applier are surgical instruments used during neurosurgical procedures for temporary or permanent occlusion of small intracranial vessels. Clips are applied using a dedicated applier. Device is used by neurosurgeons in an operating room setting. Clips provide mechanical vessel closure to facilitate surgical access or control bleeding. Benefit is effective vascular management during complex neurosurgery.

Clinical Evidence

Bench testing only. Biomechanical testing performed per FDA guidance confirms substantial equivalence to predicate devices.

Technological Characteristics

Microclips: Phynox (cobalt alloy) per ISO 5832/7. Applier: Titanium alloy per ISO 5832/3 with Phynox jaws. Available in straight or curved blade configurations. Mechanical clamping mechanism.

Indications for Use

Indicated for intracranial vascular occlusion (permanent or temporary) of small vessels in patients undergoing neurosurgical procedures.

Regulatory Classification

Identification

An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

Submission Summary (Full Text)

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4/28/03