FDA.report

510(k) K252355

Device
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Applicant
Sb-Kawasumi Laboratories, Inc.
510(k) number
K252355
Product code
PTI
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-26
Date received
2025-07-29
Regulation
880.5570
Classification name
Non-Coring (Huber) Needle
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kenichi Inamura
Address
3-25-4 Tonomachi, Kawasaki-Ku, Kawasaki-Shi Kanagawa JP 210-8602 210-8602

FDA Registration Numbers

Source Documents

510(k) summary PDF

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