510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181208Substantially Equivalent

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

Vygon U.S.A., Lansdale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181208 is the FDA 510(k) clearance record for Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter, a class II device, cleared for Vygon USA on under FDA product code PND (Midline Catheter). FDA's definition for product code PND reads: "The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days". FDA records list 4 510(k) clearances for Vygon USA, from to . As of , FDA records show one recall naming K181208.

Clearance record

Decision date
Received
(179 days to decision)
Product code
PND Midline Catheter
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Vygon USA 2750 Morris Rd., Lansdale PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PND

Trailing 12 months
1 clearance under product code PND in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PND, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260