ISO 10555-5 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
Recognition Date | 2014-01-30 |
Recognition List | 034 |
Recognition Number | 6-303 |
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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.
Regulation Number | Device Name | Device Class | Product Code |
§880.5200 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | FOZ |
Guidance of Premarket Notification [510(k) Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995 |