The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Card 43 Cardiotomy Reservoir With Phosphorylcholine Coating.
| Device ID | K061527 |
| 510k Number | K061527 |
| Device Name: | CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-02 |
| Decision Date | 2006-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250123 | K061527 | 000 |