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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 667
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K130730.
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K130730 · V-STICK VASCULAR ACCESS SET
Download PDF FDA Summary Argon Medical