The following data is part of a premarket notification filed by Vycor Medical Inc. with the FDA for Vycor Medical Viewsite Brain Access System (“vbas”) And Vbas With Alignment Clip (“vbas Ac”) (together The “vbas Family”).
| Device ID | K202694 |
| 510k Number | K202694 |
| Device Name: | Vycor Medical Viewsite Brain Access System (“VBAS”) And VBAS With Alignment Clip (“VBAS AC”) (together The “VBAS Family”) |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | Vycor Medical INC. 951 Broken Sound Parkway, STE 320 Boca Raton, FL 33487 |
| Contact | Theo Novak |
| Correspondent | Maria Griffin mdi Consultant, Inc. 55 Northem Blvd., Ste 200 Great Neck, NY 11021 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2021-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859261006258 | K202694 | 000 |
| 00859261006159 | K202694 | 000 |
| 00859261006166 | K202694 | 000 |
| 00859261006173 | K202694 | 000 |
| 00859261006180 | K202694 | 000 |
| 00859261006197 | K202694 | 000 |
| 00859261006203 | K202694 | 000 |
| 00859261006210 | K202694 | 000 |
| 00859261006227 | K202694 | 000 |
| 00859261006234 | K202694 | 000 |
| 00859261006241 | K202694 | 000 |
| 00859261006142 | K202694 | 000 |