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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 062 Date of Entry 05/29/2024 
FR Recognition Number 6-498
Standard
ISO  10555-4 Third edition 2023-11
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
Scope/Abstract
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.

This document does not specify requirements for vascular stents (see ISO 25539-2).
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FDA recognition of ISO 10555-4 Second edition 2013-06-15 [Rec# 6-322] will be superseded by recognition of ISO 10555-4 Third edition 2023-11 [Rec# 6-498].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 for Industry and FDA staff: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, issued April 2023.

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 Contacts
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@fda.hhs.gov
 Angel Soler-Garcia
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6535
  Angel.Soler-Garcia@fda.hhs.gov
 Sevan Oungoulian
  CDRH/OPEQ/OHTII/DHTIIC/
  301-796-9631
  Sevan.Oungoulian@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
General Plastic Surgery/General Hospital (primary)
Cardiovascular
*These are provided as examples and others may be applicable.
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