The following data is part of a premarket notification filed by Alcyone Lifesciences, Inc. with the FDA for Alcyone Mems Cannula (amc) System.
| Device ID | K150660 |
| 510k Number | K150660 |
| Device Name: | Alcyone MEMS Cannula (AMC) System |
| Classification | Cannula, Ventricular |
| Applicant | ALCYONE LIFESCIENCES, INC. 130 JOHN STREET, BOOT CANAL MILL BUILDING, C-2 Lowell, MA 01852 |
| Contact | Elsa Chi Abruzzo |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HCD |
| CFR Regulation Number | 882.4060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-03-13 |
| Decision Date | 2015-04-16 |
| Summary: | summary |