The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Sp Pump Head.
| Device ID | K962981 |
| 510k Number | K962981 |
| Device Name: | CAPIOX SP PUMP HEAD |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL 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 | 1996-08-01 |
| Decision Date | 1997-02-25 |