Cleared Traditional

K201170 - Athletis PTA Balloon Dilatation Catheter

K201170 is an FDA 510(k) clearance for Athletis PTA Balloon Dilatation Catheter, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K201170 · Boston Scientific Corporation · Cardiovascular device
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Sep 2020
Decision
137d
Days
Class 2
Risk

K201170 is an FDA 510(k) clearance for the Athletis PTA Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on September 15, 2020 after a review of 137 days - within the typical 510(k) review window.

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 Corporation devices

FDA 510(k) Submission Details - K201170

510(k) Number K201170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date September 15, 2020
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 347
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K201170.
JADE
K202231 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Dec 2020
Pacific Plus PTA Catheter
K202800 · Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) · Nov 2020
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · Cordis Corporation · Oct 2020
SABER .035 PTA Dilatation Catheter
K201333 · Cordis Corporation · Sep 2020
Jade
K201794 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jul 2020
Infinity Angioplasty Balloon Catheter
K192399 · Infinity Angioplasty Balloon Company, LLC · May 2020