The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 6 Dual Hollow Fiber Oxygenator With Integrated Hardshell Venous/cardiotomy Reservior.
| Device ID | K121909 |
| 510k Number | K121909 |
| Device Name: | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178112414 | K121909 | 000 |
| 38033178112391 | K121909 | 000 |