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510(k) K070143

JMS PLANECTA STOPCOCK by Jms North America Corp. — Product Code FMG

K070143 is an FDA 510(k) premarket notification submitted by Jms North America Corp. for the device "JMS PLANECTA STOPCOCK". The FDA issued a decision of Substantially Equivalent on April 10, 2007. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Jms North America Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2007
Date Received
January 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
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)
  • 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 FMG

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K223499 — Three Way Stop Cock (July 21, 2023)
  • K223175 — lntravascular Administration Sets with Stopcock and Manifold (March 10, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K210516 — Clicky Cross (May 16, 2022)
  • K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal (October 22, 2019)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)

FDA data resources