Data / Medical devices / United States / Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.)
Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.): FDA-registered device maker in Washington, NC, United States, 4 510(k) clearances
Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.) is registered with the FDA (registration 1038185) in Washington, NC, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 22, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1038185
- Address
- 209 Creekside Dr, Washington, NC, United States, 27889
- Owner or operator
- Coeur, Inc. (a wholly owned subsidiary of Illinois Tool Work (9038672)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 27, 2007
- Registered through
- 2026
- Brand names listed
- DISP. TRANSFER SETS W-WO SWAB, Disposable 330psi Extension line, Disposable 330psi Extension line w/ dual check valve, Low Pressure Injection Extension Tu
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Iodinated Contrast Media Transfer Tubing Set | PQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 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 22, 2015 | K150902 | 330psi Extension Y-Line with Dual Check Valve | DXT | Substantially Equivalent | Coeur, Inc. | accessdata.fda.gov |
| June 10, 2013 | K120892 | DISPOSABLE 330PSI EXTENSION LINES | DXT | Substantially Equivalent | Coeur, Inc. | accessdata.fda.gov |
| February 9, 2007 | K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | FPK | Substantially Equivalent | Coeur, Inc. | accessdata.fda.gov |
| March 17, 1995 | K942381 | LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING | DXT | Substantially Equivalent | Apogee, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Iodinated Contrast Media Transfer Tubing Set
- All makers of Injector And Syringe, Angiographic
- All makers of Injector, Contrast Medium, Automatic
- All makers of Set, Administration, Intravascular
- All makers of Tubing, Fluid Delivery
Updated October 22, 2015. 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.