The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Total Across.
Device ID | K133539 |
510k Number | K133539 |
Device Name: | TOTAL ACROSS |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
Contact | Diana Johnson |
Correspondent | Diana Johnson MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-18 |
Decision Date | 2014-03-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08033477052779 | K133539 | 000 |
08033477052762 | K133539 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TOTAL ACROSS 85869970 not registered Dead/Abandoned |
Medtronic Vascular, Inc. 2013-03-07 |