| ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| Recognition Date | 2012-08-20 |
| Recognition List | 029 |
| Recognition Number | 3-103 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
| FDA Tech | Nicole Ibrahim FDA/OMPT/CDRH/ODE/DCD/SHDB/ 301-796-5171 nicole.ibrahim@fda.hhs.gov |
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ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.3375 | Filter, Intravascular, Cardiovascular | Class 2 | DTK |
| There is no relevant guidance developed at this time. |