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510(k) K010264

NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET by Nipro Medical Corp. — Product Code FIB

K010264 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET". The FDA issued a decision of Substantially Equivalent on April 27, 2001. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2001
Date Received
January 29, 2001
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 Nipro Medical Corp.

  • K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (January 22, 2010)
  • K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET (October 21, 2008)
  • K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A21 (October 4, 2007)
  • K063368 — NIPRO BIOHOLE NEEDLE (February 5, 2007)
  • K063721 — NIPRO SAFETOUCH II GAMMA (January 12, 2007)
  • K052474 — NIPRO HYPODERMIC NEEDLE (November 10, 2005)
  • K051574 — NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (August 26, 2005)
  • K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (September 21, 2004)
  • K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (November 14, 2003)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)

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)
  • 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)

FDA data resources