Cleared Traditional

K143193 - Symmetry and Symmetry Stiff Shaft Ballo...

K143193 is the FDA 510(k) clearance for Symmetry and Symmetry Stiff Shaft Ballo... by Boston Scientific. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K143193 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
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Jul 2015
Decision
260d
Days
Class 2
Risk

K143193 is an FDA 510(k) clearance for the Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 260 days - an extended review 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: 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 Boston Scientific devices

Submission Details

510(k) Number K143193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2014
Decision Date July 24, 2015
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 216
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K143193.
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
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XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
Passeo-35 PTA Catheter
K142379 · Biotronik, Inc. · Dec 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · Covidien, LLC · Oct 2014