The following data is part of a premarket notification filed by Btg International, Inc. with the FDA for Ekosonic Mach 4 Endovascular Device/ekosonic Control Unit.
| Device ID | K140151 |
| 510k Number | K140151 |
| Device Name: | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT |
| Classification | Catheter, Continuous Flush |
| Applicant | BTG INTERNATIONAL, INC. 11911 NORTH CREEK PARKWAY S Bothell, WA 98011 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten BTG INTERNATIONAL, INC. 11911 NORTH CREEK PARKWAY S Bothell, WA 98011 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858593006509 | K140151 | 000 |
| 00858593006134 | K140151 | 000 |
| 00858593006141 | K140151 | 000 |
| 00858593006158 | K140151 | 000 |
| 00858593006165 | K140151 | 000 |
| 00858593006172 | K140151 | 000 |
| 00858593006189 | K140151 | 000 |
| 00858593006264 | K140151 | 000 |
| 00858593006295 | K140151 | 000 |
| 00858593006301 | K140151 | 000 |
| 00858593006318 | K140151 | 000 |
| 00858593006493 | K140151 | 000 |
| 00858593006028 | K140151 | 000 |