Arrow Pressure Injectable Midline Catheter— 510(k) K213855

Name: FDA 510(k) clearance K213855
Creator: U.S. Food and Drug Administration
Published: 2022-09-02

Substantially Equivalent

Arrow International, LLC Subsidiary of Teleflex Incorporated

FDA 510(k) clearance K213855 for Arrow Pressure Injectable Midline Catheter, Substantially Equivalent on 2022-09-02. Applicant: Arrow International, LLC Subsidiary of Teleflex Incorporated. Device class: 2.

Clearance details

Applicant: Arrow International, LLC Subsidiary of Teleflex Incorporated
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2021-12-10
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PND

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K252402 — Midline Catheter2025-12-18
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

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 →

Recalls naming K213855

K-number listed on FDA's recall record

Z-2387-2026 — Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKCClass I·Ongoing·ARROW INTERNATIONAL, LLC·20260421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213855.

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