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510(k) K100720

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING by Kawasumi Laboratories, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
March 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
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)
  • 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)
  • K022110 — KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSI (September 12, 2002)

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