ASTM F2081-06 (Reapproved 2017)

Standard Guide For Characterization And Presentation Of The Dimensional Attributes Of Vascular Stents

F2081-06 (Reapproved 2017)

Standard Organization: ASTM

ASTM F2081-06 (Reapproved 2017)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Recognition Number	Cardiovascular
Recognition Date	2019-01-14
Recognition List	051
Recognition Number	3-66
Extent	Complete standard
Standards Orgs	ASTM ASTM International http://www.astm.org/
STG	Cardiovascular
FDA Tech	Jhumur Banik FDA/OMPT/CDRH/ODE/DCD/PIDB/ 240-402-5239 Jhumur.Banik@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also included within the scope of this guide.

Code of Federal Regulations:


Regulation Number	Device Name	Device Class	Product Code
Unclassified	Coronary Drug-Eluting Stent	Class 3	NIQ
Unclassified	Stent, Carotid	Class 3	NIM
Unclassified	Stent, Coronary	Class 3	MAF
Unclassified	Stent, Iliac	Class 3	NIO
Unclassified	Stent, Renal	Class 3	NIN
Unclassified	Stent, Superficial Femoral Artery	Class 3	NIP

FDA Guidance:

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.