The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Occlusion Catheter.
| Device ID | K955125 |
| 510k Number | K955125 |
| Device Name: | LMI OCCLUSION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3808FOCC400 | K955125 | 000 |
| B3803FOCC400 | K955125 | 000 |
| B3804FOCC230 | K955125 | 000 |
| B3804FOCC400 | K955125 | 000 |
| B3805FOCC230 | K955125 | 000 |
| B3805FOCC400 | K955125 | 000 |
| B3806FOCC230 | K955125 | 000 |
| B3806FOCC400 | K955125 | 000 |
| B3807FOCC230 | K955125 | 000 |
| B3807FOCC400 | K955125 | 000 |
| B3808FOCC230 | K955125 | 000 |
| B3803FOCC230 | K955125 | 000 |