Cleared Traditional

K192399 - Infinity Angioplasty Balloon Catheter

K192399 is the FDA 510(k) clearance for Infinity Angioplasty Balloon Catheter by Infinity Angioplasty Balloon Company, LLC. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K192399 · Infinity Angioplasty Balloon Company, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
260d
Days
Class 2
Risk

K192399 is an FDA 510(k) clearance for the Infinity Angioplasty Balloon Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Infinity Angioplasty Balloon Company, LLC (Toledo, US). The FDA issued a Cleared decision on May 20, 2020 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 Infinity Angioplasty Balloon Company, LLC devices

Submission Details

510(k) Number K192399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date May 20, 2020
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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K192399.
Athletis PTA Balloon Dilatation Catheter
K201170 · Boston Scientific Corporation · Sep 2020
SABER .035 PTA Dilatation Catheter
K201333 · Cordis Corporation · Sep 2020
Jade
K201794 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jul 2020
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
K200700 · Creagh Medical, Ltd. · May 2020
All’InCath 035M PTA Balloon Dilatation Catheter
K191275 · Nexstep Medical · Jan 2020
Advocate PTA Catheter
K192907 · Merit Medical Systems, Inc. · Nov 2019