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510(k) K032977

JMS BYPASS TUBE by Jms North America Corp. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2004
Date Received
September 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
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)
  • 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)

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  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
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  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)