Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter— 510(k) K181208

Name: FDA 510(k) clearance K181208
Creator: U.S. Food and Drug Administration
Published: 2018-11-02

Substantially Equivalent

Vygon USA

FDA 510(k) clearance K181208 for Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter, Substantially Equivalent on 2018-11-02. Applicant: Vygon USA. Device class: 2.

Clearance details

Applicant: Vygon USA
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2018-05-07
Decision date: 2018-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

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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 K181208

K-number listed on FDA's recall record

Z-0585-2020 — 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001Class II·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·20190924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181208.

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