Cleared Traditional

K021638 - ILT ADVANCING MECHANISM

K021638 is an FDA 510(k) clearance for ILT ADVANCING MECHANISM, manufactured by Intra Luminal Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K021638 · Intra Luminal Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
67d
Days
Class 2
Risk

K021638 is an FDA 510(k) clearance for the ILT ADVANCING MECHANISM, MODEL A115AMI. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Intra Luminal Therapeutics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 26, 2002 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intra Luminal Therapeutics, Inc. devices

FDA 510(k) Submission Details - K021638

510(k) Number K021638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date July 26, 2002
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 598
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K021638.
ENDOVASCULAR GUIDE WIRE
K021363 · Stereotaxis, Inc. · Nov 2002
HI-TORQUE WHISPER LS
K023300 · Guidant Corp. · Oct 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target · Oct 2002
ILT TORQUER, MODEL 114TR1
K021243 · Intra Luminal Therapeutics, Inc. · Jul 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · Biotronik, Inc. · Jun 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323 · Intra Luminal Therapeutics, Inc. · May 2002