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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 the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) 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. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K252355.

When did K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing receive FDA 510(k) clearance?

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

Who is the listed applicant for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Sb-Kawasumi Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K213823Intera Refill KitIntera Oncology, 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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