The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Capiox Icp Centrifugal Pump.
| Device ID | K200091 |
| 510k Number | K200091 |
| Device Name: | Capiox ICP Centrifugal Pump |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
| Contact | John Chesney |
| Correspondent | John Chesney Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2021-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450979 | K200091 | 000 |
| 50699753450962 | K200091 | 000 |