Submission Details
| 510(k) Number | K153143 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2015 |
| Decision Date | December 02, 2015 |
| Days to Decision | 33 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Capiox Advance Hardshell Reservoir
Dec 2015
Decision
33d
Days
Class 2
Risk
About This 510(k) Submission
K153143 is an FDA 510(k) clearance for the Capiox Advance Hardshell Reservoir, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on December 2, 2015, 33 days after receiving the submission on October 30, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.
Device Classification
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4400 |
Manufacturer
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