ASTM F2394-07 (Reapproved 2017)

Standard Guide For Measuring Securement Of Balloon Expandable Vascular Stent Mounted On Delivery System

F2394-07 (Reapproved 2017)

Standard Organization: ASTM

ASTM F2394-07 (Reapproved 2017)
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

• Recognition Number: Cardiovascular
• Recognition Date: 2019-01-14
• Recognition List: 051
• Recognition Number: 3-86
• Extent: Partial recognition. The following part(s) of the standard is (are) not recognized Figure 2.2 Bottom Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System; Figure 2.3 Top Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System; Figure 2.4 Alternative Test Tracking Fixture
• 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. Figure 2.2 Bottom Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System conflicts with an existing published final guidance, see Section C2 of guidance listed below. Figure 2.3 Top Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System conflicts with an existing published final guidance, see Section C2 of the guidance listed below. Figure 2.4 Alternative Test Tracking Fixture conflicts with an existing published final guidance, see Section C2 of the guidance listed below.

Scope:

This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

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.