Data / Medical devices / United States / Vitalcor, Inc.
Vitalcor, Inc.: FDA-registered device maker in Westmont, IL, United States, 2 510(k) clearances
Vitalcor, Inc. is registered with the FDA (registration 1450019) in Westmont, IL, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 29, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450019
- Address
- 100 East Chestnut Ave., Westmont, IL, United States, 60559
- Owner or operator
- Vitalcor, Inc. (1450019)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- Applied Fiberoptics, Applied Fiberoptics a division of Vitalcor, Inc., Britetrac Retractor, Cannula With Self-inflating Balloon, Dingo Vascular Clamp, Gemini Plus, Vitalcor Coronary Artery Perfusion, Vitalcor Featherweight Vasc, Clamp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Specification developer | accessdata.fda.gov |
| Headlight, Fiberoptic Focusing | FCT | 2 | Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Specification developer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Specification developer | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 29, 2007 | K070661 | VITALCOR FEATHERWEIGHT VASCULAR CLAMPS | DXC | Substantially Equivalent | Vitalcor, Inc. | accessdata.fda.gov |
| April 18, 2003 | K030231 | CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, Fiberoptic
- All makers of Forceps, General & Plastic Surgery
- All makers of Headlight, Fiberoptic Focusing
- All makers of Retractor
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Clamp, Vascular
Updated August 29, 2007. 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.