The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Carotid Endarterectomy Shunt Catheter, Model #'s Ces, Cesr, Cesb, Cesrb, Cest, Cestr, Cestb, Cestrb, Ces-sb, Cesr-sb.
| Device ID | K983802 |
| 510k Number | K983802 |
| Device Name: | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
| Contact | Daniel Lucas |
| Correspondent | Daniel 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 | 1998-10-28 |
| Decision Date | 1999-07-30 |
| Summary: | summary |