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Arstasis Access System

by Arstasis, Inc. 510(k) 2 variants

Active United States

510(k) K102728

Overview

The ARSTASIS ACCESS SYSTEM is a high-performance cardiovascular registration device that provides accurate and reliable data for medical professionals. With its robust features and advanced technology, this device has become an essential tool in the field of cardiology.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102728 Date7 Oct 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0993-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010

    Device has the potential to fracture and sheath separation during use.

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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