Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029386

FEI Number

1000306647

Entity Name

LUCAS MEDICAL, INC.

City/State/Country

Orange, CA, US

Establishment Address

1554 North Case Street, Orange, CA 92867, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LUCAS MEDICAL, INC. (Owner Number: 9012199)

Owner / Operator Contact Address

1554 N Case Street, Orange, CA 92867, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970657

PMA Number

N/A

All Registered Proprietary Names

LMI Arterial Embolectomy Catheter LMI Biliary Catheter BI-LUMEN IRRIGATION CATHETER LMI Thrombectomy Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-06
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2007-12-06
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1995-01-09
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-06

Official Correspondent

DANIEL LUCAS, JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LUCAS MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Similar Registrations

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3035111606	GAMAMED VASCULAR SYSTEMS INC.	Loveland, CO, US
2015691	EDWARDS LIFESCIENCES LLC	IRVINE, CA, US
1220948	LEMAITRE VASCULAR, INC.	BURLINGTON, MA, US
2027111	APPLIED MEDICAL RESOURCES CORP.	RSM, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029386. Last updated year: 2026. Please use registration number 2029386 when referencing this establishment in official correspondence.