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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 6-322: ISO 10555-4 Second edition 2013-06-15, intravascular catheters -- sterile and single-use catheters -- part 4: balloon dilatation catheters. (General Plastic Surgery/General Hospital)

Date of Standard: 2013. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Single use Intravascular Catheters
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.1250 Catheter, Percutaneous Class 2 DQY
§880.5200 Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days Class 2 FOZ
Relevant Guidance:
Guidance of Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995

Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued September 8, 2010
FDA Technical Contact:
 Keith Marin
  10903 New Hampshire Avenue WO66 RM2604
  Silver Spring MD 20993
  email: keith.marin@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