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510(k) K022110

KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. by Kawasumi Laboratories, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2002
Date Received
June 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Kawasumi Laboratories, Inc.

  • K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (July 8, 2019)
  • K190233 — K-Shield Advantage Port Access Infusion Set (PAIS) (May 2, 2019)
  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (March 7, 2013)
  • K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (November 18, 2010)
  • K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR (November 3, 2010)
  • K073257 — KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR (January 25, 2008)
  • K061197 — KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER (June 30, 2006)
  • K060580 — K-SHIELD PORT ACCESS INFUSION SET (June 6, 2006)
  • K023917 — WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR (February 26, 2003)

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  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
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  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
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  • K153228 — NMI Port, NMI Port II (December 4, 2015)