Cleared Traditional

K201377 - SABERX RADIANZ Percutaneous Translumina...

K201377 is an FDA 510(k) clearance for SABERX RADIANZ Percutaneous Translumina..., manufactured by Cordis Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K201377 · Cordis Corporation · Cardiovascular device
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Oct 2020
Decision
136d
Days
Class 2
Risk

K201377 is an FDA 510(k) clearance for the SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on October 9, 2020 after a review of 136 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 Cordis Corporation devices

FDA 510(k) Submission Details - K201377

510(k) Number K201377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2020
Decision Date October 09, 2020
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K201377.
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
K210626 · Cordis Corporation · Apr 2021
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
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