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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 3-103: ISO 25539-3 First edition 2011-12-01, cardiovascular implants - endovascular devices - part 3: vena cava filters. (Cardiovascular)

Date of Standard: 2011. 
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:
Vena Cava Filters
Processes Affected:
510(k), IDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.3375 Filter, Intravascular, Cardiovascular Class 2 DTK
FDA Technical Contact:
 Nicole Ibrahim
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1546
  Silver Spring MD 20993
  301/796-5171
  email: nicole.ibrahim@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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