Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-104: ASTM F2914-12, Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices. (Cardiovascular)
Date of Standard: 2012. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
| The purose of this standard guide is to provude a guide on how to determine the appropriate attributes to evaluate in a shelf-life study. This guide was written for endovascular devices. |
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| Related CFR Citations and Product Codes: |
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 |
| Unclassified |
System, Endovascular Graft, Aortic Aneurysm Treatment |
Class 3 |
MIH |
| Unclassified |
Transcatheter Septal Occluder |
Class 3 |
MLV |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3375 |
Filter, Intravascular, Cardiovascular |
Class 2 |
DTK |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Heather Agler |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5572 |
| Silver Spring MD 20993 |
| 301/796-6340 |
| Email: heather.agler@fda.hhs.gov |
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