The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Vantage View System.
| Device ID | K110085 |
| 510k Number | K110085 |
| Device Name: | VANTAGE VIEW SYSTEM |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | ST. JUDE MEDICAL ONE ST JUDE MEDICAL DRIVE St Paul, MN 55117 -9913 |
| Contact | Kris Miller |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-11 |
| Decision Date | 2011-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067014627 | K110085 | 000 |
| 05414734218429 | K110085 | 000 |
| 05414734218436 | K110085 | 000 |
| 05415067004703 | K110085 | 000 |
| 05415067005847 | K110085 | 000 |
| 05415067010841 | K110085 | 000 |
| 05415067010858 | K110085 | 000 |
| 05415067010865 | K110085 | 000 |
| 05415067010872 | K110085 | 000 |
| 05415067013125 | K110085 | 000 |
| 05415067013132 | K110085 | 000 |
| 05415067014610 | K110085 | 000 |
| 05414734218412 | K110085 | 000 |