Cleared Traditional

K133843 - SABER PERCUTANEOUS TRANSLUMINAL ANGIOPL...

K133843 is an FDA 510(k) clearance for SABER PERCUTANEOUS TRANSLUMINAL ANGIOPL..., 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 191-day FDA review.

K133843 · Cordis Corporation · Cardiovascular device
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Jun 2014
Decision
191d
Days
Class 2
Risk

K133843 is an FDA 510(k) clearance for the SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corporation (Fremont, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 191 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 Cordis Corporation devices

FDA 510(k) Submission Details - K133843

510(k) Number K133843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date June 27, 2014
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
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 265
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