The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Navigator Tissue Dissection Device.
| Device ID | K062727 |
| 510k Number | K062727 |
| Device Name: | CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDTRONIC VASCULAR 7601 NORTHLAND DRIVE Brooklyn Park, MN 55428 -1088 |
| Contact | Scott Candy |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-10-11 |
| Summary: | summary |