Cleared Special

K131329 - VECTOR PTA BALLOON DILATATION CATHETER

K131329 is an FDA 510(k) clearance for VECTOR PTA BALLOON DILATATION CATHETER, manufactured by R4 Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 29-day FDA review.

K131329 · R4 Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
29d
Days
Class 2
Risk

K131329 is an FDA 510(k) clearance for the VECTOR PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by R4 Vascular, Inc. (Eagan, US). The FDA issued a Cleared decision on June 6, 2013 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 R4 Vascular, Inc. devices

FDA 510(k) Submission Details - K131329

510(k) Number K131329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2013
Decision Date June 06, 2013
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 262
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K131329.
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K132020 · Cook, Inc. · Oct 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · Boston Scientific Corp · Oct 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · Ev3, Inc. · Sep 2013
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K130293 · Cook, Inc. · May 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · Bard Peripheral Vascular, Inc. · May 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · Ev3, Inc. · May 2013