The following data is part of a premarket notification filed by Vycor Medical Llc with the FDA for Vycor Surgical Access Systems.
| Device ID | K060973 |
| 510k Number | K060973 |
| Device Name: | VYCOR SURGICAL ACCESS SYSTEMS |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | VYCOR MEDICAL LLC 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859261006135 | K060973 | 000 |
| 00859261006012 | K060973 | 000 |
| 00859261006029 | K060973 | 000 |
| 00859261006036 | K060973 | 000 |
| 00859261006043 | K060973 | 000 |
| 00859261006050 | K060973 | 000 |
| 00859261006067 | K060973 | 000 |
| 00859261006074 | K060973 | 000 |
| 00859261006081 | K060973 | 000 |
| 00859261006098 | K060973 | 000 |
| 00859261006104 | K060973 | 000 |
| 00859261006111 | K060973 | 000 |
| 00859261006128 | K060973 | 000 |
| 00859261006005 | K060973 | 000 |