The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capiox Sp Pump With X-coating Product Code: Cxsp45x.
| Device ID | K012209 |
| 510k Number | K012209 |
| Device Name: | CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-15 |
| Summary: | summary |