Data / Medical devices / United States / Cook, Inc.
Cook, Inc.: FDA-registered device maker in Bloomington, IN, United States, 1 510(k) clearance
Cook, Inc. is registered with the FDA (registration 3012766489) in Bloomington, IN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012766489
- Address
- 1700 N Curry Pike, Bloomington, IN, United States, 47404
- Owner or operator
- COOK, INC. (1820334)
- Roles
- Manufacturer
- First device listed
- January 4, 2018
- Registered through
- 2026
- Brand names listed
- Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Torcon NB Advantage Angiographic Catheter, Beacon Tip White Vessel Sizing Catheter, Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
Updated November 15, 2017. 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.