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 |