Ashitaka Factory of Terumo Corp. · Class II · Cleared Mar 13, 2013
| K-number | K130520 |
| Device name | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR |
| Applicant | Ashitaka Factory of Terumo Corp. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Mar 13, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov