Non-PVC Fluid Path Port Access Infusion Set With Slit Septum Injection Site

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964117 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Kawasumi Laboratories Co., Ltd. →

• What is the primary purpose of this infusion set?

  This device is designed to access implanted medication ports, allowing for the delivery of medications into a patient's system via an intravascular route.

• What regulatory classification does this device fall under?

  This device is classified as an implanted, subcutaneous, intravascular port and catheter under FDA regulation number 880.5965 and has received FDA 510(k) clearance for use in general hospital settings.

• What are the key features of this infusion set?

  The set features a non-PVC fluid path and includes a slit septum injection site, which is specifically engineered to facilitate reliable access to implanted ports.