Cleared Traditional

K192399 - Infinity Angioplasty Balloon Catheter

K192399 is an FDA 510(k) clearance for Infinity Angioplasty Balloon Catheter, manufactured by Infinity Angioplasty Balloon Company, LLC. The device is a Class 2 Cardiovascular device with 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)
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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

FDA 510(k) Submission Details - K192399

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.

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 K192399.
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