ISO 10555-4 Second edition 2013-06-15

Standard Organization:

ISO 10555-4 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters

Recognition Date2014-01-30
Recognition List034
Recognition Number6-322
Extent Complete standard
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:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

Code of Federal Regulations:

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

FDA Guidance:

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


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