Cleared Traditional

Atlas Gold PTA Dilatation Catheter (K181323) - FDA 510(k) Clearance

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

K181323 · C.R. Bard, Inc. · Cardiovascular device
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Aug 2018
Decision
77d
Days
Class 2
Risk

K181323 is an FDA 510(k) clearance for the Atlas Gold PTA Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on August 3, 2018 after a review of 77 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. 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K181323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date August 03, 2018
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 177
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K181323.
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · Apr 2019
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
K181529 · Contego Medical, LLC · Dec 2018
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
K181128 · Contego Medical, LLC · Sep 2018
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K180007 · Creagh Medical, Ltd. · Apr 2018
Admiral Xtreme
K173515 · Medtronic Vascular · Apr 2018
Jade PTA Balloon Dilatation Catheter
K173894 · Orbusneich Medical Trading, Inc. · Feb 2018