510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992664Substantially Equivalent

Tfx Medical Stylet Catheter

Tfx Medical Group, Jeffrey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992664 is the FDA 510(k) clearance record for TFX MEDICAL STYLET CATHETER, a class II device, cleared for Tfx Medical Group on under FDA product code DRB (Stylet, Catheter). FDA records list 3 510(k) clearances for Tfx Medical Group, from to . As of , FDA records show no recalls naming K992664.

Clearance record

Decision date
Received
(248 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Tfx Medical Group Tall Pines Park, Jeffrey NH
510(k) summary
Summary
Third party review
No

Clearances, product code DRB

Trailing 12 months

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

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, 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