| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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6-408
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| Standard | |
ISO 10555-1 Second edition 2013-06-15
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
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Scope/Abstract| ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
When this standard is used to support a regulatory submission for an interventional or diagnostic cardiovascular catheter (e.g. balloon angioplasty catheter or stent delivery system), Section 4.6 (Peak Tensile Force) is not recognized.
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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.
This standard is recognized in part because "Section 4.6 (Peak Tensile Force)" is in conflict with an existing published final guidance, see Section VII.B. of the FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, issued September 8, 2010. |
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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, Umbilical Artery
|
Class 2
|
FOS
|
| §880.5200 |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
Class 2
|
FOZ
|
| §880.5200 |
Saline, Vascular Access Flush
|
Class 2
|
NGT
|
| §880.5200 |
Heparin, Vascular Access Flush
|
Class 2
|
NZW
|
| §880.5200 |
Water, Vascular Access Flush
|
Class 2
|
NZX
|
| §880.5200 |
Peripheral Catheter Insertion Kit
|
Class 2
|
OWL
|
| §880.5200 |
Heparin Flush In 0.45% Sodium Chloride
|
Class 2
|
PEF
|
| §880.5200 |
Central Venous Catheter Dressing Change Kit
|
Class 2
|
PEZ
|
| §880.5970 |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
Class 2
|
LJS
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 1995.
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued September 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. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
