Formula 418 Vascular Balloon-Expandable Stent System

Conditional

COOK INCORPORATED

Peripheral artery stent, bare-metal

Non-clinical testing has demonstrated that the Formula 418 Vascular Stent is MR Conditional according to ASTM

F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

A patient with this stent can be scanned safely anytime after placement under the following conditions.

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