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510(k) K072988

NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 by Nipro Medical Corporation — Product Code FIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2008
Date Received
October 23, 2007
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

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  • K161681 — Nipro SafeTouch IV Catheter (March 8, 2017)
  • K160444 — FB-U Hemodialyzer (February 8, 2017)
  • K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter (January 14, 2016)
  • K140191 — ELISIO-H HEMODIALYZER (April 14, 2014)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • 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)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)