The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Sjm/cad Isoflow(tm) Centrifugal Pump 2100cp, Modif.
| Device ID | K912604 |
| 510k Number | K912604 |
| Device Name: | SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | Joseph Curtis |
| Correspondent | Joseph Curtis ARIES 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 | 1991-05-31 |
| Decision Date | 1991-10-28 |