The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Sarns Centrifugal Pump With Xcoating, Model 164275x.
| Device ID | K020998 |
| 510k Number | K020998 |
| Device Name: | SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry Courtney |
| Correspondent | Garry Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-28 |
| Decision Date | 2002-04-04 |
| Summary: | summary |