SurgicalPreview
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Endo Vantage, LLC
The following data is part of a premarket notification filed by Endo Vantage, Llc with the FDA for Surgicalpreview.
Pre-market Notification Details
| Device ID | K171534 |
| 510k Number | K171534 |
| Device Name: | SurgicalPreview |
| Classification | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Applicant | Endo Vantage, LLC 1475 N Scottsdale Road, Suite 200 Scottsdale, AZ 85257 |
| Contact | Robert S. Green |
| Correspondent | H. Semih Oktay CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis, MD 21401 |
| Product Code | PZO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2017-11-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B642SURGICALPREVIEW2300 | K171534 | 000 |
| B642SURGICALPREVIEW3100 | K171534 | 000 |
| B642SURGICALPREVIEW3000 | K171534 | 000 |
| B642SURGICALPREVIEW2600 | K171534 | 000 |
| B642SURGICALPREVIEW2500 | K171534 | 000 |
| B642SURGICALPREVIEW2400 | K171534 | 000 |
| B642SURGICALPREVIEW100 | K171534 | 000 |
| B642SURGICALPREVIEW1100 | K171534 | 000 |
| B642SURGICALPREVIEW1200 | K171534 | 000 |
| B642SURGICALPREVIEW2100 | K171534 | 000 |
| B642SURGICALPREVIEW2200 | K171534 | 000 |
| B642SURGICALPREVIEW3200 | K171534 | 000 |
Trademark Results [SurgicalPreview]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGICALPREVIEW 87324106 5342953 Live/Registered |
EndoVantage, LLC 2017-02-03 |
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