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510(k) K032975

JMS BLOOD TUBING SETS by Jms North America Corp. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2004
Date Received
September 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Jms North America Corp.

  • K093637 — JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 82 (February 9, 2010)
  • K082882 — A.V. FISTULA BLUNT NEEDLE SET (January 21, 2009)
  • K070234 — JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS (May 22, 2007)
  • K070143 — JMS PLANECTA STOPCOCK (April 10, 2007)
  • K051814 — JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET (August 4, 2005)
  • K032977 — JMS BYPASS TUBE (May 25, 2004)
  • K040247 — PLUME SAFETY AVF NEEDLE (March 3, 2004)
  • K030479 — JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET (August 18, 2003)
  • K023668 — JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PL (July 1, 2003)

Other clearances for product code FJK

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  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)