Cleared Special

K103143 - ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

K103143 is an FDA 510(k) clearance for ARSTASIS ONE LATCHWIRE ACCESS SYSTEM, manufactured by Arstasis, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 100-day FDA review.

K103143 · Arstasis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
100d
Days
Class 2
Risk

K103143 is an FDA 510(k) clearance for the ARSTASIS ONE LATCHWIRE ACCESS SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arstasis, Inc. (San Carlos, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 100 days - within the typical 510(k) review window.

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 - K103143

510(k) Number K103143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date February 02, 2011
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 662
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