RX HERCULINK PLUS BILIARY STENT SYSTEM

• K Number: K010684
• Device Name: RX HERCULINK PLUS BILIARY STENT SYSTEM
• Manufacturer: GUIDANT CORP.
• Date Cleared: 2001-04-12 ( 35 days)
• Product Code: FGE
• Regulation Number: 876.5010
• Type: Special
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.