Cleared Traditional

TFX MEDICAL STYLET CATHETER (K992664) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992664 · Tfx Medical Group · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
248d
Days
Class 2
Risk

K992664 is an FDA 510(k) clearance for the TFX MEDICAL STYLET CATHETER. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Tfx Medical Group (Jeffrey, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 248 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Tfx Medical Group devices

Submission Details

510(k) Number K992664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date April 13, 2000
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRB Stylet, Catheter

All 9
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K992664.
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988
OBTURATOR
K770404 · Abbott Laboratories · Mar 1977