| 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
|
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. |
|
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
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
