The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Tracelet Compression Device.
| Device ID | K162027 |
| 510k Number | K162027 |
| Device Name: | TRAcelet Compression Device |
| Classification | Clamp, Vascular |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Colleen Mullins |
| Correspondent | Colleen Mullins MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169900909 | K162027 | 000 |
| 20643169900893 | K162027 | 000 |