Cook Incorporated

FDA Device Registration & Listing · Canton, IL, US · Registration 3011050534

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011050534
FEI Number
3011050534
Entity Name
Cook Incorporated
City/State/Country
Canton, IL, US
Establishment Address
300 E Elm St, Canton, IL 61520, 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
N
Expiration Date (Year)
2026
510(k) Number
K180054
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 Royal Flush Plus High-Flow 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
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-11-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-04-06

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
3012766489 COOK, INC. Bloomington, IN, 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011050534. Last updated year: 2026. Please use registration number 3011050534 when referencing this establishment in official correspondence.
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