Midline Catheter— 510(k) K252402

Name: FDA 510(k) clearance K252402
Creator: U.S. Food and Drug Administration
Published: 2025-12-18

Substantially Equivalent

Terumo Medical Products (Hangzhou) Co., Ltd.

FDA 510(k) clearance K252402 for Midline Catheter, Substantially Equivalent on 2025-12-18. Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2025-07-31
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PND

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K213855 — Arrow Pressure Injectable Midline Catheter2022-09-02
K213203 — Provena(TM) Midline Catheter2022-05-13
K210047 — Stiletto Extended Dwell Catheter2021-08-27
K192802 — primeMidline Catheters2019-10-28
K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter2018-11-02

More clearances from Terumo Medical Products (Hangzhou) Co., Ltd.

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K252398 — SURFLO Hybria Closed System Safety IV Catheter2025-12-17
K221411 — Surflo Winged Infusion Set2023-06-23
K220934 — RADIFOCUS Torque Device2022-06-29
K031279 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET2003-05-30

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.