Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027553380

FEI Number

3027553380

Entity Name

CATHTEK LLC

City/State/Country

Walkertown, NC, US

Establishment Address

4790 Walkertown Plaza Blvd, Walkertown, NC 27051, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cathtek LLC (Owner Number: 10042470)

Owner / Operator Contact Address

3825 Reidsville Road, Winston Salem, NC 27101, 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
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-06-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-11-26
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-11-25
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-07-19
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2024-07-19

Official Correspondent

Jessica Hughes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cathtek 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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

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8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
8043862	AAP IMPLANTATE AG	BERLIN, DE
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027553380. Last updated year: 2026. Please use registration number 3027553380 when referencing this establishment in official correspondence.