Cleared Special

K130730 - V-STICK VASCULAR ACCESS SET

K130730 is an FDA 510(k) clearance for V-STICK VASCULAR ACCESS SET, manufactured by Argon Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 249-day FDA review.

K130730 · Argon Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
249d
Days
Class 2
Risk

K130730 is an FDA 510(k) clearance for the V-STICK VASCULAR ACCESS SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Argon Medical (Gainesville, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Argon Medical devices

FDA 510(k) Submission Details - K130730

510(k) Number K130730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date November 22, 2013
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 485
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K130730.
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K132720 · Merit Medical Systems, Inc. · Feb 2014
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013