Cleared Special

K132263 - AXERA 2 ACCESS SYSTEM

K132263 is an FDA 510(k) clearance for AXERA 2 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 28-day FDA review.

K132263 · Arstasis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
28d
Days
Class 2
Risk

K132263 is an FDA 510(k) clearance for the AXERA 2 ACCESS SYSTEM. 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 August 19, 2013 after a review of 28 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K132263

510(k) Number K132263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2013
Decision Date August 19, 2013
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K132263.
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
K131148 · Access Scientific, LLC · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013
AMECO SHEATH INTRODUCER
K131144 · Ameco Medical Industries · Aug 2013
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
K131079 · Creganna Medical Devices · Aug 2013