Intrastent Doublestrut XS Stent

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

510(k) Number

K000864 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Intracoil Peripheral Stent

  Class II

  FDA 510(k) K990221 Active Cleared 2 Jun 1999

• Intrastent Doublestrut Paramount Biliary Endoprosthesis

  Class II

  FDA 510(k) K003450 Active Cleared 7 Dec 2000

• Iti Intramax Guide Catheter 91, 78 and 65

  Class II

  FDA 510(k) K981191 Active Cleared 7 Apr 1999

• Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K003040 Active Cleared 28 Dec 2000

• Intrastent

  Class II

  FDA 510(k) K991929 Active Cleared 4 Aug 1999

• Intrastent Doublestrut Paramount

  Class II

  FDA 510(k) K001648 Active Cleared 28 Aug 2000

See all devices from Intratherapeutics, Inc. →

• What is the primary clinical purpose of the Intrastent Doublestrut XS Stent?

  This device is a biliary catheter used for the temporary or prolonged drainage of the biliary tract. It is also indicated for splinting the bile duct during the healing process and for preventing the formation of strictures within the bile duct.

• What is the regulatory status of this device?

  The Intrastent Doublestrut XS Stent is authorized under FDA 510(k) number K000864. It is classified under regulation number 876.5010 within the gastroenterology and urology medical specialties.

• How is this device categorized for medical use?

  The device is categorized as a stent, drain, or dilator for the biliary ducts. It is designed as a tubular, flexible accessory device to assist in maintaining biliary patency.