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FDA 510(k)

Midline Catheter

K-Number: K252402 · 2025-12-18

ApplicantTerumo Medical Products (Hangzhou) Co., Ltd.
Decision Date2025-12-18
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Midline Catheter is a medical device manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-18 under approval number K252402. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Midline Catheter?

Midline Catheter is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K252402.

When was Midline Catheter approved by the FDA?

Midline Catheter received FDA 510(k) clearance on 2025-12-18, under approval number K252402.

What company makes Midline Catheter?

Midline Catheter is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd..

What is the FDA product code for Midline Catheter?

The FDA product code for Midline Catheter is PND.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT06979167 Complications of Midline Catheter in Surgical Children COMPLETED NCT06770374 Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients RECRUITING NCT06884176 CVCs Versus Midline Catheters NOT_YET_RECRUITING

Other Devices by Terumo Medical Products (Hangzhou) Co., Ltd.

K220934RADIFOCUS Torque Device K221411Surflo Winged Infusion Set K252398SURFLO Hybria Closed System Safety IV Catheter

Related Devices (Code: PND)

K162900PowerMidline CatheterC.R. Bard, Inc. K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) K153393PowerMidline CatheterC.R. Bard, Inc. K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.) K170770CT MidlineMedical Components, Inc. (dba MedComp) K170158PowerGlide ST Midline CatheterC.R. Bard, 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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