Cleared Traditional

K053310 - VASCON ROAMER MICROCATHETER

K053310 is an FDA 510(k) clearance for VASCON ROAMER MICROCATHETER, manufactured by Vascon, LLC. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 948-day FDA review.

K053310 · Vascon, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
948d
Days
Class 2
Risk

K053310 is an FDA 510(k) clearance for the VASCON ROAMER MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Vascon, LLC (Miami, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 948 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K053310

510(k) Number K053310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2005
Decision Date July 03, 2008
Days to Decision 948 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
823d slower than avg
Panel avg: 125d · This submission: 948d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 173
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K053310.
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
K082163 · Flowmedica, Inc. · Oct 2008
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
CLARIVEIN CATHETER
K071468 · Vascular Insights, LLC · Mar 2008
VARICATH PERIPHERAL INFUSION CATHETER
K073400 · Veinrx, Inc. · Dec 2007
K053310 · VASCON ROAMER MICROCATHETER
Download PDF FDA Summary Vascon, LLC