Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015489752

FEI Number

3015489752

Entity Name

C2Dx, Inc.

City/State/Country

Schoolcraft, MI, US

Establishment Address

555 E Eliza St, Suite A, Schoolcraft, MI 49087, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Critical Care Diagnostics, Inc (Owner Number: 10059775)

Owner / Operator Contact Address

555 E Eliza St, Schoolcraft, MI 49087, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K844214

PMA Number

N/A

All Registered Proprietary Names

Fixed Core Wire Guide Advance® Salivary Balloon Catheter with Wire Guide Salivary Access Dilator Set 7013-8050 HANDLE FOR MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM CONTROLLER; 7013-8400 MODEL P8400 HEMOSTATIX THERMAL 7013-5712 MODEL 5712 BLADE (QTY 24) FOR MODEL 600D, 2400Z, AND P8400 THERMAL SCALPEL SYSTEM CONTROLLERS; 7023-5712 MODEL 7013-5810 - Hemostatix Thermal System #10 Blade - Qty 24; 7013-5815 - Hemostatix Thermal Scalpel System #15 Blade - QTY NCircle® and NGage® Salivary Stone Extractor SialoCath® Salivary Duct Catheter Kolenda Salivary Access Introducer Set Mul T Pad T-Pump Temp Pump Pro Mul T Blanket T Pump STIC Intra-Compartmental Pressure Monitor System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-02-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-02-02
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-02-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-02-02
OAJ	Catheter, Drainage, Intraoral/Extraoral	General, Plastic Surgery	Class 1	878.4200	2026-02-02
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-01-27
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2019-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Critical Care Diagnostics, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1220850	E. Benson Hood Laboratories, Inc.	Pembroke, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-06	Stryker Instruments Div. of Stryker Corporation	U	Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
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.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015489752. Last updated year: 2026. Please use registration number 3015489752 when referencing this establishment in official correspondence.