ISO 10555-1 Second edition 2013-06-15

Standard Organization:

ISO 10555-1 Second edition 2013-06-15
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements

Recognition Date	2015-08-14
Recognition List	040
Recognition Number	6-301
Extent	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. 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.
Standards Orgs	ISO International Organization for Standardization https://www.iso.org/
STG	General Plastic Surgery/General Hospital
FDA Tech	Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@fda.hhs.gov

Rationale:

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Scope:

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.5970	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class 2	LJS
§880.5200	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class 2	FOZ
§880.5200	Catheter, Umbilical Artery	Class 2	FOS
§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
§870.1250	Catheter, Angioplasty, Peripheral, Transluminal	Class 2	LIT
§870.1250	Catheter, Percutaneous	Class 2	DQY

FDA Guidance:

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.