Cleared Special

K020161 - AGILTRAC .018 PERIPHERAL DILATATION CAT...

K020161 is the FDA 510(k) clearance for AGILTRAC .018 PERIPHERAL DILATATION CAT... by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 36-day FDA review.

K020161 · Guidant Corp. · Cardiovascular device
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Feb 2002
Decision
36d
Days
Class 2
Risk

K020161 is an FDA 510(k) clearance for the AGILTRAC .018 PERIPHERAL DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guidant Corp. devices

Submission Details

510(k) Number K020161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2002
Decision Date February 22, 2002
Days to Decision 36 days
Submission Type Special
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
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K020161.
EASYTRAK GUIDING CATHETER
K021284 · Guidant Corp. · May 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · Medtronic Vascular · Apr 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · Medtronic Vascular · Feb 2002
6F MACH1/34356-XXX
K020028 · Boston Scientific · Jan 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002