Medtronic Vascular · Class II · Cleared Sep 15, 1999
| K-number | K992910 |
| Device name | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) |
| Applicant | Medtronic Vascular |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Sep 15, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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