The following data is part of a premarket notification filed by Terumo Cardiovascular Systems with the FDA for Sarn Centrifugal Pump.
| Device ID | K112229 |
| 510k Number | K112229 |
| Device Name: | SARN CENTRIFUGAL PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS 6200 JACKSON RD Ann Arbor, MI 48103 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen TERUMO CARDIOVASCULAR SYSTEMS 6200 JACKSON RD Ann Arbor, MI 48103 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-03 |
| Decision Date | 2011-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00699753450417 | K112229 | 000 |
| 50699753450344 | K112229 | 000 |
| 50699753450337 | K112229 | 000 |
| 50699753450320 | K112229 | 000 |
| 00699753002333 | K112229 | 000 |