The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Capiox Sp Pump Head.
| Device ID | K943861 |
| 510k Number | K943861 |
| Device Name: | CAPIOX SP PUMP HEAD |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1995-08-15 |