The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Irrigation Catheter (igr).
| Device ID | K972623 |
| 510k Number | K972623 |
| Device Name: | LMI IRRIGATION CATHETER (IGR) |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-11-19 |
| Summary: | summary |