510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860746Substantially Equivalent

Auto Syringe Micro Vol Ext Set W/air Vent Filter

Travenol Laboratories, S.A., Hooksett NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860746 is the FDA 510(k) clearance record for AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER, a class II device, cleared for Travenol Laboratories, S.A. on under FDA product code FPB (Filter, Infusion Line). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show 2 recalls naming K860746.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Travenol Laboratories, S.A. Londonderry Tpke., Hooksett NH
Third party review
No

Clearances, product code FPB

Trailing 12 months
1 clearance under product code FPB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260