Cleared Traditional

K140201 - AXERA 2 ACCESS SYSTEM

K140201 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 Traditional 510(k) pathway after a 60-day FDA review.

K140201 · Arstasis, Inc. · Cardiovascular device
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Mar 2014
Decision
60d
Days
Class 2
Risk

K140201 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 March 28, 2014 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arstasis, Inc. devices

FDA 510(k) Submission Details - K140201

510(k) Number K140201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date March 28, 2014
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 K140201.
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