Data / Medical devices / United States / Cook Incorporated
Cook Incorporated: FDA-registered device maker in Canton, IL, United States, 4 510(k) clearances
Cook Incorporated is registered with the FDA (registration 3011050534) in Canton, IL, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 5, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011050534
- Address
- 300 E Elm St, Canton, IL, United States, 61520
- Owner or operator
- COOK, INC. (1820334)
- Roles
- Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2026
- Brand names listed
- Aintree Intubation Catheter with Rapi-Fit Adapter, Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Torcon NB Advantage Angiographic Catheter, Beacon Tip White Vessel Sizing Catheter, Cook Airway Exchange Catheter with Rapi-Fit Adapters, Royal Flush Plus High-Flow Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2018 | K180054 | Royal Flush Plus High-Flow Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 15, 2017 | K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 11, 2017 | K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | BSR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 9, 2015 | K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | DQO | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Stylet, Tracheal Tube
- All makers of Tube, Tracheal (W/Wo Connector)
Updated October 5, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.