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510(k) K974829

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) by Kawasumi Laboratories Co., Ltd. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1998
Date Received
December 24, 1997
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 Co., Ltd.

  • K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET (March 8, 2000)
  • K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (March 14, 1997)
  • K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER (February 10, 1994)
  • K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER (February 3, 1994)
  • K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION (February 3, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921901 — PORT ACCESS INFUSION SET (September 10, 1993)
  • K921902 — PORT ACCESS NEEDLE (July 28, 1993)
  • K923323 — INTERMITTENT INJECTION SITE (July 13, 1993)
  • K896894 — KAWASUMI BLOOD ADMINISTRATION SET (September 12, 1990)

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