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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-90: ISO 7198 First edition 1998-08-01, cardiovascular implants - tubular vascular prostheses. (Cardiovascular)

Date of Standard: 1998. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Vascular Graft Prostheses
Processes Affected:
510(k), PMA, IDE, PDP, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.3450 Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class 2 DSY
§870.3450 Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Class 2 DYF
Relevant Guidance:
Special Controls for Vascular Prostheses

Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Protheses (NOTE: The FDA document predates the AAMI standard. Information covered by AAMI Standard supersedes the FDA document)
FDA Technical Contact:
 Dorothy Abel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1204
  Silver Spring MD 20993
  301/796-6366
  email: dorothy.abel@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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