Cleared Special

K190753 - EverCrossTM 0.035 OTW PTA Dilatation Ca...

K190753 is the FDA 510(k) clearance for EverCrossTM 0.035 OTW PTA Dilatation Ca... by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 29-day FDA review.

K190753 · Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · Cardiovascular device
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Apr 2019
Decision
29d
Days
Class 2
Risk

K190753 is an FDA 510(k) clearance for the EverCrossTM 0.035 OTW PTA Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) (Plymouth, US). The FDA issued a Cleared decision on April 23, 2019 after a review of 29 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 Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) devices

Submission Details

510(k) Number K190753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2019
Decision Date April 23, 2019
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K190753.
Advocate PTA Catheter
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K190037 · Nipro Medical Corporation · Oct 2019
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · Bard Peripheral Vascular, Inc. · Oct 2019
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
K181529 · Contego Medical, LLC · Dec 2018
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
K181128 · Contego Medical, LLC · Sep 2018
Atlas Gold PTA Dilatation Catheter
K181323 · C.R. Bard, Inc. · Aug 2018