The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Inspire Svr 1200, Inspire 6f C, Inspire 8f C.
| Device ID | K161733 |
| 510k Number | K161733 |
| Device Name: | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | Sorin Group Italia S.r.l 86, Via Statale 12 Nord Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Scott Light Sorin Group USA, Inc. 14401 W 65th Way Arvada, CO 80004 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178113015 | K161733 | 000 |