The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Capiox Nx19 Oxygenator With Reservoir (east Orientation), Terumo Capiox Nx19 Oxygenator With Reservoir (west Orientation), Terumo Capiox Nx19 Oxygenator (east Orientation), Terumo Capiox Nx19 Oxygenator (west Orientation).
| Device ID | K180950 |
| 510k Number | K180950 |
| Device Name: | Terumo Capiox NX19 Oxygenator With Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator With Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Adam Pickholtz |
| Correspondent | Adam Pickholtz Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-04-11 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450993 | K180950 | 000 |
| 50699753450917 | K180950 | 000 |
| 50699753451006 | K180950 | 000 |
| 50699753451013 | K180950 | 000 |
| 50699753450863 | K180950 | 000 |
| 50699753450870 | K180950 | 000 |
| 50699753450887 | K180950 | 000 |
| 50699753450894 | K180950 | 000 |
| 50699753450986 | K180950 | 000 |
| 50699753450900 | K180950 | 000 |