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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 6-322
Standard
ISO  10555-4 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
Scope/Abstract
ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 10555-4 Second edition 2013-06-15 [Rec# 6-322] will be superseded by recognition of ISO 10555-4 Third edition 2023-11 [Rec# 6-498]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-322] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 6-322] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class 2 FOZ
Relevant FDA Guidance and/or Supportive Publications*
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

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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