Medtronic Vascular · Class II · Cleared Feb 25, 2000
| K-number | K000430 |
| Device name | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 |
| Applicant | Medtronic Vascular |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Feb 25, 2000 |
| 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