Submission Details
| 510(k) Number | K162027 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2016 |
| Decision Date | October 21, 2016 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
TRAcelet Compression Device
Oct 2016
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K162027 is an FDA 510(k) clearance for the TRAcelet Compression Device, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on October 21, 2016, 91 days after receiving the submission on July 22, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.
Device Classification
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4450 |
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