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510(k) K040247

PLUME SAFETY AVF NEEDLE by Jms North America Corp. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2004
Date Received
February 3, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
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)
  • 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)
  • K032975 — JMS BLOOD TUBING SETS (August 16, 2004)
  • K032977 — JMS BYPASS TUBE (May 25, 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 FIE

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  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)