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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 6-301: ISO 10555-1 Second edition 2013-07-01, sterile, single-use intravascular catheters - part 1: general requirements. (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
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Single-Use Intravascular Catheters
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Central Venous Catheter Dressing Change Kit Class 2 PEZ
§880.5200 Heparin Flush In 0.45% Sodium Chloride Class 2 PEF
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5970 Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days Class 2 LJS
Relevant Guidance:
Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995
FDA Technical Contact:
 Keith Marin
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2567
  Silver Spring MD 20993
  301/796-2462
  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
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