510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963981Substantially Equivalent

Vygon Bionector with Extension Set

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

K963981 is the FDA 510(k) clearance record for VYGON BIONECTOR WITH EXTENSION SET, a class II device, cleared for Vygon Corp. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 11 510(k) clearances for Vygon Corp., from to . As of , FDA records show 14 recalls naming K963981.

Clearance record

Decision date
Received
(134 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Vygon Corp. 1129 Bloomfield Ave., West Cadwell NJ
510(k) summary
Statement
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA 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 FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260