Cleared Special

K151317 - Armada 18 PTA Catheter

K151317 is an FDA 510(k) clearance for Armada 18 PTA Catheter, manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 49-day FDA review.

K151317 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
49d
Days
Class 2
Risk

K151317 is an FDA 510(k) clearance for the Armada 18 PTA Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on July 6, 2015 after a review of 49 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 Abbott Vascular devices

FDA 510(k) Submission Details - K151317

510(k) Number K151317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date July 06, 2015
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

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 344
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K151317.
Pirouette 018
K151153 · Arravasc Limited · Aug 2015
ComboCath OTW PTA Dilatation Catheter
K150452 · Summa Therapeutics, LLC · Aug 2015
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · Boston Scientific · Jul 2015
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
K143093 · Hotspur Technologies, Inc., · Jun 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
K143041 · Natec Medical , Ltd. · Jun 2015