TOTAL ACROSS
Catheter, Percutaneous
MEDTRONIC VASCULAR
The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Total Across.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033477052779 | K133539 | 000 |
| 08033477052762 | K133539 | 000 |
Trademark Results [TOTAL ACROSS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOTAL ACROSS 85869970 not registered Dead/Abandoned |
Medtronic Vascular, Inc. 2013-03-07 |
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