FDA.report

510(k) K252402

Device
Midline Catheter
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
510(k) number
K252402
Product code
PND
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-18
Date received
2025-07-31
Regulation
880.5200
Classification name
Midline Catheter
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
Kimberly Jacob-Paredes
Address
M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou CN 310018 310018

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K192802primeMidline CathetersPfm Medical, Inc.2019-10-28
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K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)2017-12-15
K170770CT MidlineMedical Components, Inc. (dba MedComp)2017-07-25
K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.2017-06-01
K162900PowerMidline CatheterC.R. Bard, Inc.2016-12-14
K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-08-24
K153393PowerMidline CatheterC.R. Bard, Inc.2016-06-28