The following data is part of a premarket notification filed by Emba Medical Limited with the FDA for Emba Hourglass Peripheral Embolization Device.
| Device ID | K171845 |
| 510k Number | K171845 |
| Device Name: | EMBA Hourglass Peripheral Embolization Device |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | EMBA Medical Limited 3451 Commerce Pkwy Miramar, FL 33025 |
| Contact | Veronica Reott |
| Correspondent | Randy Prebula Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002787107 | K171845 | 000 |