The following data is part of a premarket notification filed by Alcyone Lifesciences. Inc. with the FDA for Alivio Ventricular Catheter And Flusher System (alivio System).
| Device ID | K172006 |
| 510k Number | K172006 |
| Device Name: | Alivio Ventricular Catheter And Flusher System (Alivio System) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Alcyone Lifesciences. Inc. 250 Jackson Street Mill No. 5, Unit 494 Lowell, MA 01852 |
| Contact | Pj Anand |
| Correspondent | Elsa Chi Abruzzo Cyngus Regulatory 3753 Vineyard Place Cincinnati, OH 45226 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860024001816 | K172006 | 000 |