Cleared Abbreviated

K071468 - CLARIVEIN CATHETER

K071468 is an FDA 510(k) clearance for CLARIVEIN CATHETER, manufactured by Vascular Insights, LLC. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Abbreviated 510(k) pathway after a 296-day FDA review.

K071468 · Vascular Insights, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
296d
Days
Class 2
Risk

K071468 is an FDA 510(k) clearance for the CLARIVEIN CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Vascular Insights, LLC (Madison, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 296 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vascular Insights, LLC devices

FDA 510(k) Submission Details - K071468

510(k) Number K071468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date March 20, 2008
Days to Decision 296 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 125d · This submission: 296d
Pathway characteristics
Standards-based clearance path.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 134
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K071468.
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · Terumo Medical Corp. · Sep 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · Cook, Inc. · Aug 2008
ENDOWAVE INFUSION SYSTEM
K073166 · Ekos Corp. · Apr 2008
CXI SUPPORT CATHETER
K072724 · Cook, Inc. · Nov 2007
PULL TAB SQUEEZE FLUSH
K070979 · Icu Medical, Inc. · Sep 2007
ARGON CONTINUOUS FLUSH DEVICE
K070384 · Argon Medical Devices, Inc. · Mar 2007