Data / Medical devices / United States / Vycor Medical Inc
Vycor Medical Inc: FDA-registered device maker in Boca Raton, FL, United States, 2 510(k) clearances
Vycor Medical Inc is registered with the FDA (registration 3005880844) in Boca Raton, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 14, 2021. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005880844
- Address
- 951 Broken Sound Pkwy Ste 320, Boca Raton, FL, United States, 33487
- Owner or operator
- VYCOR MEDICAL INC (9085664)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 17, 2006
- Registered through
- 2026
- Brand names listed
- VBAS Extension Arm, VYCOR VIEWSITE SUR, Vycor Medical Viewsite Brain Access System with Alignment Clip (VBAS AC)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 14, 2021 | K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) | GZT | Substantially Equivalent | Vycor Medical, Inc. | accessdata.fda.gov |
| July 26, 2006 | K060973 | VYCOR SURGICAL ACCESS SYSTEMS | GZT | Substantially Equivalent | Vycor Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 21, 2012 | 63319 | Class I | Terminated | Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissu | Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, Self-Retaining, For Neurosurgery
- All makers of Clamp, Surgical, General & Plastic Surgery
Updated January 14, 2021. 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.