Submission Details
| 510(k) Number | K161287 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | May 09, 2016 |
| Decision Date | August 19, 2016 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
Aug 2016
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K161287 is an FDA 510(k) clearance for the DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on August 19, 2016, 102 days after receiving the submission on May 9, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
Manufacturer
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