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510(k) K093637

JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 by Jms North America Corp. — Product Code FIE

K093637 is an FDA 510(k) premarket notification submitted by Jms North America Corp. for the device "JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300". The FDA issued a decision of Substantially Equivalent on February 9, 2010. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Jms North America Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2010
Date Received
November 24, 2009
Clearance Type
Traditional
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.

  • 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)
  • 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 FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • 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)

FDA data resources