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FDA 510(k)

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

K-Number: K252355 · 2025-11-26

ApplicantSb-Kawasumi Laboratories, Inc.
Decision Date2025-11-26
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is a medical device manufactured by Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under approval number K252355. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K252355.

When was K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing approved by the FDA?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing received FDA 510(k) clearance on 2025-11-26, under approval number K252355.

What company makes K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is manufactured by Sb-Kawasumi Laboratories, Inc..

What is the FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

The FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is PTI.

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Other Devices by Sb-Kawasumi Laboratories, Inc.

K220799K-SHIELD Zen K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K241855SB Knife Jr2 (MD-47702 and MD-47702L)

Related Devices (Code: PTI)

K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc. K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc. K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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