Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012833053

FEI Number

3012833053

Entity Name

PATHWAY MEDTECH, LLC.

City/State/Country

Santee, CA, US

Establishment Address

8779 Cottonwood Ave Ste 105, Santee, CA 92071, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pathway Medtech, LLC. (Owner Number: 10052260)

Owner / Operator Contact Address

8779 Cottonwood Ave, Suite 105, Santee, CA 92071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2024-11-21
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2025-02-19
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2025-02-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-11-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-11-10
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2020-11-17
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-12-03
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-10-17
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-10-18
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2025-05-05

Official Correspondent

Arthur Deptala

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pathway Medtech, LLC.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3026820968	NEURGAIN TECHNOLOGIES	La Jolla, CA, US
3006247277	OPTICO LTD	LETCHWORTH Hertfordshire, GB
3005621335	DEVEMED GMBH	NEUHAUSEN OB ECK Baden-Wurttemberg, DE
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US
3012995405	SURGIX MEDICAL LLC	Spring, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012833053. Last updated year: 2026. Please use registration number 3012833053 when referencing this establishment in official correspondence.