The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Bmr1900 Ph.i.s.i.o Venous Reservoir Bag.
| Device ID | K112771 |
| 510k Number | K112771 |
| Device Name: | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada, CO 80004 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-23 |
| Decision Date | 2011-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250383 | K112771 | 000 |
| 38033178109551 | K112771 | 000 |