Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007138831

FEI Number

3007138831

Entity Name

ALLWELL MEDICAL CORPORATION

City/State/Country

Raleigh, NC, US

Establishment Address

7424 Chapel Hill Rd 204, Raleigh, NC 27607, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Allwell Medical Corporation (Owner Number: 10024817)

Owner / Operator Contact Address

7424 Chapel Hill Rd 204, Raleigh, NC 27607, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141753

PMA Number

N/A

All Registered Proprietary Names

Inflation Syringe Kit Inflation Device Presure Monitoring Tube Introducer (Guide Wire Insertion To Homostasis Valve Angioplasty Pack Stockcocks Allwell Nastrogastric Feeding Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2008-02-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2010-05-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-02-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-06-26
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2010-05-29
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2018-09-08
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2018-09-08

Official Correspondent

Jeff Wang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Allwell Medical Corporation

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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

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3002834291	MIAN SHAHID CORP.	MUZAFFAR PUR, SIALKOT Punjab, PK
1125782	MERIT MEDICAL SYSTEMS, INC	Chester, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007138831. Last updated year: 2026. Please use registration number 3007138831 when referencing this establishment in official correspondence.