The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Bilumen Irrigation Arterial Embolectomy Cahteter.
| Device ID | K955499 |
| 510k Number | K955499 |
| Device Name: | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| 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 | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B380NL9IRR30D0 | K955499 | 000 |
| B3804FIRR040P0 | K955499 | 000 |
| B3804FIRR080D0 | K955499 | 000 |
| B3804FIRR080P0 | K955499 | 000 |
| B3805FIRR040D0 | K955499 | 000 |
| B3805FIRR040P0 | K955499 | 000 |
| B3805FIRR080D0 | K955499 | 000 |
| B3805FIRR080P0 | K955499 | 000 |
| B3806FIRR040D0 | K955499 | 000 |
| B3806FIRR040P0 | K955499 | 000 |
| B3806FIRR080D0 | K955499 | 000 |
| B3806FIRR080P0 | K955499 | 000 |
| B3807FIRR040D0 | K955499 | 000 |
| B3807FIRR040P0 | K955499 | 000 |
| B3807FIRR080D0 | K955499 | 000 |
| B3807FIRR080P0 | K955499 | 000 |
| B380NL12IRR30D0 | K955499 | 000 |
| B3804FIRR040D0 | K955499 | 000 |