The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Centrifugal Pump 5 (cp5).
| Device ID | K112225 |
| 510k Number | K112225 |
| Device Name: | SORIN CENTRIFUGAL PUMP 5 (CP5) |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-03 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817902782 | K112225 | 000 |
| 04033817901501 | K112225 | 000 |
| 04033817901006 | K112225 | 000 |
| 04033817900955 | K112225 | 000 |
| 04033817900948 | K112225 | 000 |
| 04033817900733 | K112225 | 000 |