Cleared Special

K073400 - VARICATH PERIPHERAL INFUSION CATHETER

K073400 is an FDA 510(k) clearance for VARICATH PERIPHERAL INFUSION CATHETER, manufactured by Veinrx, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 16-day FDA review.

K073400 · Veinrx, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
16d
Days
Class 2
Risk

K073400 is an FDA 510(k) clearance for the VARICATH PERIPHERAL INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Veinrx, Inc. (Miami, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 - K073400

510(k) Number K073400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date December 20, 2007
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K073400.
VASCON ROAMER MICROCATHETER
K053310 · Vascon, LLC · Jul 2008
ENDOWAVE INFUSION SYSTEM
K073166 · Ekos Corp. · Apr 2008
CLARIVEIN CATHETER
K071468 · Vascular Insights, LLC · Mar 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
K073400 · VARICATH PERIPHERAL INFUSION CATHETER
Download PDF FDA Summary Veinrx, Inc.