The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Lifestream Centrifugal Pump System Model 2100cp.
| Device ID | K921550 |
| 510k Number | K921550 |
| Device Name: | LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | Joseph Curtis |
| Correspondent | Joseph Curtis ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-05-21 |