510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851005Substantially Equivalent

Xro Umbilical Catheter-Code 270

Vygon Corp., East Rutherford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851005 is the FDA 510(k) clearance record for XRO UMBILICAL CATHETER-CODE 270, a class II device, cleared for Vygon Corp. on under FDA product code FOS (Catheter, Umbilical Artery). FDA records list 13 510(k) clearances for Vygon Corp., from to . As of , FDA records show no recalls naming K851005.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FOS Catheter, Umbilical Artery
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Vygon Corp. 1 Madison St., East Rutherford NJ
Third party review
No

Clearances, product code FOS

Trailing 12 months

FDA records hold no clearances under product code FOS in the trailing twelve months.

FDA records show no clearances under product code FOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260