| ISO 10555-4 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 6-322 |
| 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 |
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 10555-4:2013 specifies requirements for balloon dilatation catheters 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 |
| §870.1250 | Catheter, Angioplasty, Peripheral, Transluminal | Class 2 | LIT |
| §870.1250 | Catheter, Percutaneous | Class 2 | DQY |
| 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 |