The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Lifestream Centrifugel Pump Interface #210pi.
| Device ID | K933014 |
| 510k Number | K933014 |
| Device Name: | LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | Joseph Magliozzi |
| Correspondent | Joseph Magliozzi 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 | 1993-06-21 |
| Decision Date | 1994-09-28 |