Cleared Traditional

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210626 · Cordis Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
52d
Days
Class 2
Risk

K210626 is an FDA 510(k) clearance for the SABER .035 Percutaneous Transluminal Angioplasty (PTA) 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 April 23, 2021 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corporation devices

Submission Details

510(k) Number K210626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2021
Decision Date April 23, 2021
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K210626.
Chocolate PTA Balloon Catheter
K213631 · Medtronic, Inc. · Dec 2021
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
K201246 · Qualimed USA, LLC · Aug 2021
Sublime Radial Access 018 RX Dilatation Catheter
K211044 · Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · Jun 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
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · Cordis Corporation · Oct 2020