The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Capiox Rx Hollow Fiber Oxygenator With/without Hardshell Reservoir.
| Device ID | K153213 |
| 510k Number | K153213 |
| Device Name: | Capiox RX Hollow Fiber Oxygenator With/without Hardshell Reservoir |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Tierra A Brown |
| Correspondent | Tierra A Brown Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | DTZ |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2015-12-03 |
| Summary: | summary |