Terumo Cardiovascular Systems Corp. · Class II · Cleared Dec 11, 2001
| K-number | K010443 |
| Device name | CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING |
| Applicant | Terumo Cardiovascular Systems Corp. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Dec 11, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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