Atlas FDA

Midline Catheter

FDA 510(k) clearance K252402 · decided 2025-12-18

Clearance details

K-number
K252402
Device name
Midline Catheter
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
Decision
Substantially Equivalent
Date received
2025-07-31
Decision date
2025-12-18
Days to decision
140 days
Clearance type
Traditional
Product code
PND
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Arrow Pressure Injectable Midline Catheter (K213855)Arrow International, LLC Subsidiary of Teleflex Incorporated2022-09-02
Provena(TM) Midline Catheter (K213203)C.R. Bard, Inc.2022-05-13
Stiletto Extended Dwell Catheter (K210047)Piper Access, LLC2021-08-27
primeMidline Catheters (K192802)Pfm Medical, Inc.2019-10-28
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208)Vygon USA2018-11-02
primeMidline Catheters (K173114)Pfm Medical, Inc.2018-03-07
ArchFlo CT Midline (K171483)Medcomp (Dba Medical Components, Inc.)2017-12-15
CT Midline (K170770)Medical Components, Inc. (dba MedComp)2017-07-25
PowerGlide ST Midline Catheter (K170158)C.R. Bard, Inc.2017-06-01
PowerMidline Catheter (K162900)C.R. Bard, Inc.2016-12-14
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-08-24
PowerMidline Catheter (K153393)C.R. Bard, Inc.2016-06-28

Recalls involving this device

No recalls on record reference this clearance.