The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Capiox Advance Hardshell Reservoir.
| Device ID | K153143 |
| 510k Number | K153143 |
| Device Name: | Capiox Advance Hardshell Reservoir |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2015-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450771 | K153143 | 000 |