Intrastent Doublestrut Ld

• • Terminated Z-0829-06 FDA Unclassified (pre-2012) ·initiated 29 Dec 2005

  IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)

510(k) Number

K993904 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• 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

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