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510(k) K073318

BIPORE BALLOON DILATION CATHETER by Bipore, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2008
Date Received
November 26, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Bipore, Inc.

  • K073434 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (April 1, 2008)
  • K051513 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (December 7, 2005)
  • 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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