The following data is part of a premarket notification filed by Ka Medical, Llc with the FDA for Dr. Amplatz Micro Plug.
| Device ID | K182944 |
| 510k Number | K182944 |
| Device Name: | Dr. Amplatz Micro Plug |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | KA Medical, LLC 2890 Centre Pointe Drive Roseville, MN 55113 |
| Contact | John Oslund |
| Correspondent | Karen Bannick KA Medical, LLC 2890 Centre Pointe Drive Roseville, MN 55113 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2019-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867966000136 | K182944 | 000 |
| 00867966000129 | K182944 | 000 |
| 00867966000112 | K182944 | 000 |
| 00867966000105 | K182944 | 000 |