Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009883402

FEI Number

3009883402

Entity Name

Boston Scientific Cardiac Diagnostic Technologies, Inc.

City/State/Country

ROCHESTER, MN, US

Establishment Address

2900 37th Street NW, Building 003, ROCHESTER, MN 55901, US

Establishment Type(s)

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

Owner / Operator

Boston Scientific Corporation (Owner Number: 9912058)

Owner / Operator Contact Address

300 Boston Scientific Way, Marlborough, MA 01752, 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
QYX	Outpatient Cardiac Telemetry	Cardiovascular	Class 2	870.1025	2026-03-20
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-03-20
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2021-10-28
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2021-10-28

Official Correspondent

Adrienne Bishop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Scientific Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025434462	Obsidio Inc	Maple Grove, MN, US
3005619880	Boston Scientific Corporation	Roswell, GA, US
3015425075	NALU MEDICAL	Carlsbad, CA, US
3015289131	FARAPULSE, INC.	Menlo Park, CA, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K891148	Del Mar Avionics	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	1989-05-11
K914092	Nihon Kohden America, Inc.	BSM-2100A CONFIGURED PATIENT MONITOR	1992-05-28
K153473	Braemar Manufacturing, LLC	Braemar Telemetry Patch System	2016-07-22
K151681	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-07-17
K150310	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3011937459	VivaQuant, Inc	Arden Hills, MN, US
3007770164	MEDICALGORITHMICS S.A.	WARSAW Mazowieckie, PL
3011265784	Rhythmedix	Mount Laurel, NJ, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US
3029904429	SMARTCARDIA SA	Lausanne Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009883402. Last updated year: 2026. Please use registration number 3009883402 when referencing this establishment in official correspondence.