Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012766489

FEI Number

3012766489

Entity Name

COOK, INC.

City/State/Country

Bloomington, IN, US

Establishment Address

1700 N Curry Pike, Bloomington, IN 47404, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COOK, INC. (Owner Number: 1820334)

Owner / Operator Contact Address

750 DANIELS WAY, Bloomington, IN 47404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173289

PMA Number

N/A

All Registered Proprietary Names

Beacon Tip Torcon NB Advantage Angiographic Catheter Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter Beacon Tip Centimeter Sizing Catheter Beacon Tip Cava Vessel Sizing Catheter Beacon Tip White Vessel Sizing Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK, 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
3011050534	Cook Incorporated	Canton, IL, US
1825146	Cook Incorporated	Spencer, IN, US
1000393132	COOK INCORPORATED	ELLETTSVILLE, IN, US
1820334	Cook Incorporated	Bloomington, IN, US

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

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3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012766489. Last updated year: 2026. Please use registration number 3012766489 when referencing this establishment in official correspondence.