• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 3-91: ISO 5840 Fourth edition 2005-03-01, cardiovascular implants - cardiac valve prostheses. (Cardiovascular)

Date of Standard: 2005. 
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:
Replacement Heart Valves
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical
Extent of Recognition:
COmplete standard and any annexes, except for exclusions, differences, and additions in the relevant guidance
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Heart-Valve, Allograft Class 3 MIE
Unclassified Heart-Valve, Mechanical Class 3 LWQ
Unclassified Heart-Valve, Non-Allograft Tissue Class 3 LWR
Unclassified Pulmonic Valved Conduit Class f MWH
Unclassified Pulmonary Valve Prosthesis Percutaneously Delivered Class f NPV
§870.3925 Replacement Heart-Valve Class 3 DYE
Relevant Guidance:
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
FDA Technical Contact:
 Carolyn Vaughan
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1230
  Silver Spring MD 20993
  301/796-6338
  email: carolyn.vaughan@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
-
-