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510(k) K070234

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS by Jms North America Corp. — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
January 16, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
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)
  • K070143 — JMS PLANECTA STOPCOCK (April 10, 2007)
  • K051814 — JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET (August 4, 2005)
  • K032975 — JMS BLOOD TUBING SETS (August 16, 2004)
  • 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 MPB

  • K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter (August 12, 2025)
  • K200426 — Acute Dual Lumen Hemodialysis Catheter (December 24, 2020)
  • K192807 — Duo-Flow Side x Side Double Lumen Catheter (April 23, 2020)
  • K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurk (January 17, 2020)
  • K163458 — Zenysis Short-Term Dialysis Catheter (April 4, 2017)
  • K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (January 6, 2017)
  • K153190 — Zenysis Short-Term Dialysis Catheter (January 5, 2016)
  • K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO H (July 29, 2013)
  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)