Submission Details
| 510(k) Number | K161733 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2016 |
| Decision Date | March 08, 2017 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Mar 2017
Decision
258d
Days
Class 2
Risk
About This 510(k) Submission
K161733 is an FDA 510(k) clearance for the INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 8, 2017, 258 days after receiving the submission on June 23, 2016. 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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