Cleared Traditional

K991647 - TFX MEDICAL INTRODUCER KIT

K991647 is an FDA 510(k) clearance for TFX MEDICAL INTRODUCER KIT, manufactured by Tfx Medical Group. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K991647 · Tfx Medical Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
236d
Days
Class 2
Risk

K991647 is an FDA 510(k) clearance for the TFX MEDICAL INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Tfx Medical Group (Jeffrey, US). The FDA issued a Cleared decision on January 4, 2000 after a review of 236 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 - K991647

510(k) Number K991647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date January 04, 2000
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 563
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K991647.
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
K000824 · Medamicus, Inc. · Apr 2000
TFX MEDICAL INTRODUCER ASSEMBLY
K993191 · Tfx Medical, Inc. · Mar 2000
IN-LINE HEMOSTASIS VALVE
K990975 · Merit Medical Systems, Inc. · Mar 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp · Jan 2000
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · Boston Scientific Corp · Oct 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · Adam Spence Corp. · Jul 1999