Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
FDA 510(k) clearance K202694 · decided 2021-01-14
Clearance details
- K-number
- K202694
- Device name
- Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
- Applicant
- Vycor Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-16
- Decision date
- 2021-01-14
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- GZT
- Device class
- 2
- Regulation number
- 882.4800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.