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510(k) K862015

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER by Bipore, Inc. — Product Code FIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1986
Date Received
May 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)
  • 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)
  • K844625 — BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY (January 16, 1985)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (February 21, 2008)
  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (June 7, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)