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510(k) K983650

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1999
Date Received
October 16, 1998
Clearance Type
Traditional
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)
  • K073318 — BIPORE BALLOON DILATION CATHETER (January 16, 2008)
  • K051513 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (December 7, 2005)
  • K041293 — BIOPORE BALLOON DILATION CATHETER (July 9, 2004)
  • 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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