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
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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.

View all Arstasis, Inc. devices

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
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 483
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K123135.
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
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EQUAFLOW MULTIVALVE INFUSION CATHETER
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K122431 · Thomas Medical Products, Inc. · Jan 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
K122926 · Baylis Medical Co., Inc. · Jan 2013
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · Oscor, Inc. · Dec 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · Oscor, Inc. · Dec 2012