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Recognized Consensus Standards
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Recognition List Number: 026 Publication Date: 03/18/2011 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 3-54: AAMI / ANSI / ISO 7198:1998/2001/(R)2010, Cardiovascular implants - Tubular vascular prostheses. (Cardiovascular)

Date of Standard: 2010. 
Addresses of Standards Organizations:
  Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
  American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
  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, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical
Extent of Recognition:
Complete Standard

NOTE: This standard identifies critical parameters for the various types of vascular prostheses and provides guidance on development of appropriate test methods. It does not contain acceptance criteria for the parameters. Additional information as outlined in the Guidance referenced below must be provided.
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

Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions
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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