The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Modification To: Stockert S5 System.
| Device ID | K071318 |
| 510k Number | K071318 |
| Device Name: | MODIFICATION TO: STOCKERT S5 SYSTEM |
| Classification | Console, Heart-lung Machine, 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 | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34033817900635 | K071318 | 000 |
| 34033817900628 | K071318 | 000 |
| 04033817903147 | K071318 | 000 |
| 04033817903130 | K071318 | 000 |