The following data is part of a premarket notification filed by Embolic Acceleration, Llc with the FDA for Emba Hourglass Peripheral Embolization Device (ped).
| Device ID | K200083 |
| 510k Number | K200083 |
| Device Name: | EMBA Hourglass Peripheral Embolization Device (PED) |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Embolic Acceleration, LLC 3451 Commerce Pkwy Miramar, FL 33025 |
| Contact | Veronica Mcdougall |
| Correspondent | Veronica Mcdougall Embolic Acceleration, LLC 3451 Commerce Pkwy Miramar, FL 33025 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-15 |
| Decision Date | 2020-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002787114 | K200083 | 000 |