TFX Medical Stylet Catheter

FDA 510(k) K992664 · Tfx Medical Group

Substantially Equivalent

510(k) numberK992664

Submission

Device name
TFX Medical Stylet Catheter
Applicant
Tfx Medical Group
Jeffrey, NH, US
Received
August 9, 1999
Decision date
April 13, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRB – Stylet, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1380
Specialty
Cardiovascular

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Questions and answers

When was TFX Medical Stylet Catheter cleared by the FDA?

TFX Medical Stylet Catheter (K992664) received a 510(k) decision of Substantially Equivalent on April 13, 2000, 248 days after the submission was received.

What is the product code of K992664?

The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.