Cleared Traditional

K992664 - TFX MEDICAL STYLET CATHETER

K992664 is an FDA 510(k) clearance for TFX MEDICAL STYLET CATHETER, manufactured by Tfx Medical Group. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K992664 · Tfx Medical Group · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K992664

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
Combination Product No
PCCP Authorized No
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.

DRB Device Classification - Class 2, Special Controls

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 18
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
ENSTYLET MODELS EC0010, EC0020
K993376 · Endocardial Solutions, Inc. · Jan 2000
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · Spectranetics Corp. · Oct 1999