Arstasis Access System

by Arstasis, Inc. 510(k) 2 variants

Active United States

510(k) K100615

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK100615	Date30 Mar 2010Cleared	StatusActive

Coverage

1 jurisdiction

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Withdrawn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: K100615
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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