The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae.
| Device ID | K162215 |
| 510k Number | K162215 |
| Device Name: | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L 86, VIA STATALE 12 NORD Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Scott Light PAREXEL CONSULTING LLC 14401 W. 65TH WAY Arvada, CO 80004 -3599 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2017-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178011991 | K162215 | 000 |
| 38033178004788 | K162215 | 000 |
| 38033178004856 | K162215 | 000 |
| 38033178004962 | K162215 | 000 |
| 38033178004979 | K162215 | 000 |
| 38033178004986 | K162215 | 000 |
| 38033178005075 | K162215 | 000 |
| 38033178005181 | K162215 | 000 |
| 38033178005204 | K162215 | 000 |
| 38033178005440 | K162215 | 000 |
| 38033178005549 | K162215 | 000 |
| 38033178005556 | K162215 | 000 |
| 38033178011410 | K162215 | 000 |
| 38033178011427 | K162215 | 000 |
| 38033178011458 | K162215 | 000 |
| 38033178011472 | K162215 | 000 |
| 38033178011496 | K162215 | 000 |
| 38033178011861 | K162215 | 000 |
| 38033178003897 | K162215 | 000 |