Cleared Special

K143652 - Vector PTA Balloon Dilatation Catheter

K143652 is an FDA 510(k) clearance for Vector PTA Balloon Dilatation Catheter, manufactured by Vector Corporation, LLC. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 65-day FDA review.

K143652 · Vector Corporation, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
65d
Days
Class 2
Risk

K143652 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 Vector Corporation, LLC (New York, US). The FDA issued a Cleared decision on February 26, 2015 after a review of 65 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.

FDA 510(k) Submission Details - K143652

510(k) Number K143652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date February 26, 2015
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 Consultant

Honkanen Consulting, Inc.
Laurie Lewandowski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 382
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K143652.
ELM PTA Balloon Dilatation Catheter
K143561 · O'Connell Regulatory Consultants, Inc. · May 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
K150946 · Ostial Corporation · May 2015
Ebony PTA 0.035 Peripheral Dilatation Catheter
K143036 · Natec Medical , Ltd. · Mar 2015
Ebony PTA 0.014 RX Peripheral Dilatation Catheter
K142459 · Natec Medical , Ltd. · Feb 2015
Passeo-35 PTA Catheter
K142379 · Biotronik, Inc. · Dec 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · Covidien, LLC · Oct 2014
K143652 · Vector PTA Balloon Dilatation Catheter
Download PDF FDA Summary Vector Corporation, L…