The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for St.jude Medical Pulse 2100 Centrifugal Pump.
| Device ID | K894255 |
| 510k Number | K894255 |
| Device Name: | ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ST. JUDE MEDICAL, INC. 825 NORTH 300 WEST Salt Lake City, UT 84103 |
| Contact | Terry Dahl |
| Correspondent | Terry Dahl ST. JUDE MEDICAL, INC. 825 NORTH 300 WEST Salt Lake City, UT 84103 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-20 |
| Decision Date | 1989-09-26 |