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 |