Data / Medical devices / United States / Lucas Medical, Inc.
Lucas Medical, Inc.: FDA-registered device maker in Orange, CA, United States, 6 510(k) clearances
Lucas Medical, Inc. is registered with the FDA (registration 2029386) in Orange, CA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 30, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2029386
- FEI number
- 1000306647
- Address
- 1554 North Case Street, Orange, CA, United States, 92867
- Owner or operator
- LUCAS MEDICAL, INC. (9012199)
- Roles
- Manufacturer
- First device listed
- January 9, 1995
- Registered through
- 2026
- Brand names listed
- Arterial Bilumen Irrigation Cathete, BI-LUMEN IRRIGATION CATHETER, Carotid Endarterectomy Shunt Cathet, LMI Arterial Embolectomy Catheter, LMI Biliary Catheter, LMI Thrombectomy Catheter, Occlusion Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Embolectomy | DXE | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 1999 | K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | MJN | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| July 1, 1997 | K970657 | LMI THROMBECTOMY CATHETER | DXE | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| May 10, 1996 | K955126 | LMI BILIARY CATHETER | FGE | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| April 11, 1996 | K954760 | LMI ARTERIAL EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| March 11, 1996 | K955125 | LMI OCCLUSION CATHETER | DXE | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
| February 28, 1996 | K955499 | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER | MJN | Substantially Equivalent | Lucas Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Catheter, Embolectomy
- All makers of Catheter, Intravascular Occluding, Temporary
- All makers of Catheter, Irrigation
Updated July 30, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.