The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 8 Dual Hollow Fiber Oxygenator With With Integrated Hardshell Venous/cardiotomy.
| Device ID | K121229 |
| 510k Number | K121229 |
| Device Name: | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178112407 | K121229 | 000 |
| 38033178112308 | K121229 | 000 |