Bipore Accuflex Percutaneous Sheath Introducer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K073434 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bipore Accuflex Percutaneous Sheath Introducer

  Class II

  FDA 510(k) K964814 Active Cleared 7 May 1997

• O.2 Micron Infection Resistant Hydrophobic Filter

  Class II

  FDA 510(k) K862015 Active Cleared 22 Jul 1986

• Biopore Balloon Dilation Catheter

  Class II

  FDA 510(k) K041293 Active Cleared 9 Jul 2004

• Bipore Balloon Dilatation Catheter

  Class II

  FDA 510(k) K961980 Active Cleared 12 Sep 1996

• Bipore Balloon Dilation Catheter

  Class II

  FDA 510(k) K073318 Active Cleared 16 Jan 2008

• Bipore O.2 Micron Hydrophobic Filter Assembly

  Class I

  FDA 510(k) K844625 Active Cleared 16 Jan 1985

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