Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009443693

FEI Number

3009443693

Entity Name

VectraCor, Inc.

City/State/Country

Totowa, NJ, US

Establishment Address

785 Totowa Rd Suite 100, Totowa, NJ 07512, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VectraCor, Inc. (Owner Number: 10038931)

Owner / Operator Contact Address

785 Totowa Rod, Suite 100, Totowa, NJ 07512, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140852

PMA Number

N/A

All Registered Proprietary Names

V300 Platnium VectraCor Platinum Trillium Platinum Vet Eidos 5003 V300 Silver V300 Platinum Vet VectraCor Platinum Vet VectraCor Silver V300 Gold VectraCor Gold Nose Clips Holter Prep Kit Universal SmartECG VectraplexECG System with VectraplexAMI V300 Holter Recorder V300 Holter Monitor Electrode Vectraplex CMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-12-19
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2016-09-06
OJW	Shave Prep Kit	General, Plastic Surgery	Class 2	878.4370	2016-08-22
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2018-08-31
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-08-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-11-25
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2011-11-25
LOS	N/A	N/A	Class N/A	N/A	2011-11-25
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2024-12-19
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2016-09-06
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-09-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-09-06
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2016-09-06

Official Correspondent

Brad Schreck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VectraCor, 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
2133542	VectraCor, Inc.	Maple Grove, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009443693. Last updated year: 2026. Please use registration number 3009443693 when referencing this establishment in official correspondence.