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Vycor Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0673-2013Class IVycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: TAugust 21, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (togethJanuary 14, 2021
K060973VYCOR SURGICAL ACCESS SYSTEMSJuly 26, 2006