Cleared Traditional

K123135 - AXERA 2 ACCESS SYSTEM MODEL AXE200

K123135 is an FDA 510(k) clearance for AXERA 2 ACCESS SYSTEM MODEL AXE200, manufactured by Arstasis, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K123135 · Arstasis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
115d
Days
Class 2
Risk

K123135 is an FDA 510(k) clearance for the AXERA 2 ACCESS SYSTEM MODEL AXE200. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arstasis, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 28, 2013 after a review of 115 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K123135

510(k) Number K123135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2012
Decision Date January 28, 2013
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01271946 Completed Interventional Industry-sponsored

A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

351
Patients (actual)
8
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Zoltan Turi, MD
Sponsor Arstasis, Inc. (industry)
Started 2010-11-01 → Primary completion 2011-05-01
Primary outcome
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Secondary outcome
Time to Hemostasis
View full study on ClinicalTrials.gov

Regulatory Peers - DYB Introducer, Catheter

All 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K123135.
PERCUTANEOUS INTRODUCER KIT
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ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
K122854 · Arrow International (Subsidiary of Teleflex Inc.) · Jan 2013