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510(k) K190485

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) by Kawasumi Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2019
Date Received
February 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Kawasumi Laboratories, Inc.

  • 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)
  • K022110 — KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSI (September 12, 2002)

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