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510(k) K051513

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER by Bipore, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2005
Date Received
June 2, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Bipore, Inc.

  • K073434 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (April 1, 2008)
  • K073318 — BIPORE BALLOON DILATION CATHETER (January 16, 2008)
  • K041293 — BIOPORE BALLOON DILATION CATHETER (July 9, 2004)
  • K983650 — BIPORE BALLOON DILATATION CATHETER (February 17, 1999)
  • K973563 — BIPORE BALLOON DILATATION CATHETER (April 1, 1998)
  • K964814 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (May 7, 1997)
  • K961980 — BIPORE BALLOON DILATATION CATHETER (September 12, 1996)
  • K862015 — O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER (July 22, 1986)
  • K844625 — BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY (January 16, 1985)

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