The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Stockert Centrifugal Pump Plus System (scp Plus), Models 60-00-10, 60-00-55.
| Device ID | K091008 |
| 510k Number | K091008 |
| Device Name: | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 |
| 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 | 2009-04-09 |
| Decision Date | 2009-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817901457 | K091008 | 000 |
| 04033817900962 | K091008 | 000 |