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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR 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 Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Endovascular devices
Processes Affected:
510(k), PMA, IDE, HDE
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.
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
§870.3375 Filter, Intravascular, Cardiovascular Class 2 DTK
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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