Submission Details
| 510(k) Number | K162215 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 08, 2016 |
| Decision Date | June 16, 2017 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K162215 - Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
(FDA 510(k) Clearance)
Jun 2017
Decision
312d
Days
Class 2
Risk
K162215 is an FDA 510(k) clearance for the Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF).
Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 16, 2017, 312 days after receiving the submission on August 8, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Similar Devices — DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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