The following data is part of a premarket notification filed by Telemed with the FDA for Micrus.
| Device ID | K161968 |
| 510k Number | K161968 |
| Device Name: | MicrUs |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TELEMED Dariaus Ir Gireno Str.42 Vilnius, LT Lt-02189 |
| Contact | Yury Sokolov |
| Correspondent | Yury Sokolov Medical Imaging Innovations Dariaus Ir Gireno Str. 42 Vilnius, LT |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04772057000147 | K161968 | 000 |
| 04772057000130 | K161968 | 000 |
| 04772057000123 | K161968 | 000 |
| 04772057000116 | K161968 | 000 |
| 04772057000109 | K161968 | 000 |
| 04772057000352 | K161968 | 000 |
| 04772057000345 | K161968 | 000 |
| 04772057000338 | K161968 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICRUS 75210504 2527722 Dead/Cancelled |
DEPUY SYNTHES, INC. 1996-11-29 |
![]() MICRUS 75161438 not registered Dead/Abandoned |
ALOKA CO., LTD. 1996-09-05 |
![]() MICRUS 74569686 2063680 Dead/Cancelled |
MICRUS HOLDINGS INC. 1994-09-06 |