The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Pureflex Arterial Cannulae.
| Device ID | K180979 |
| 510k Number | K180979 |
| Device Name: | PureFlex Arterial 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 LivaNova USA, Inc. 14401 West 65th Way Arvada, CO 80004 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178017139 | K180979 | 000 |
| 38033178016941 | K180979 | 000 |
| 38033178016934 | K180979 | 000 |
| 38033178016927 | K180979 | 000 |
| 38033178016910 | K180979 | 000 |
| 38033178016903 | K180979 | 000 |
| 38033178016897 | K180979 | 000 |
| 38033178016880 | K180979 | 000 |
| 38033178016873 | K180979 | 000 |
| 38033178016866 | K180979 | 000 |
| 38033178016859 | K180979 | 000 |
| 38033178016842 | K180979 | 000 |
| 38033178016835 | K180979 | 000 |
| 38033178016828 | K180979 | 000 |
| 38033178016811 | K180979 | 000 |
| 38033178016804 | K180979 | 000 |
| 38033178016798 | K180979 | 000 |
| 38033178016958 | K180979 | 000 |
| 38033178016965 | K180979 | 000 |
| 38033178017122 | K180979 | 000 |
| 38033178017115 | K180979 | 000 |
| 38033178017108 | K180979 | 000 |
| 38033178017092 | K180979 | 000 |
| 38033178017085 | K180979 | 000 |
| 38033178017078 | K180979 | 000 |
| 38033178017061 | K180979 | 000 |
| 38033178017054 | K180979 | 000 |
| 38033178017047 | K180979 | 000 |
| 38033178017030 | K180979 | 000 |
| 38033178017023 | K180979 | 000 |
| 38033178017016 | K180979 | 000 |
| 38033178017009 | K180979 | 000 |
| 38033178016996 | K180979 | 000 |
| 38033178016989 | K180979 | 000 |
| 38033178016972 | K180979 | 000 |
| 38033178016781 | K180979 | 000 |