Vycor Medical, Inc.
Vycor Medical, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0673-2013, Class I) was initiated on August 21, 2012. Its most recent 510(k) clearance was granted on January 14, 2021.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0673-2013 | Class I | Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: T | August 21, 2012 |