Submission Details
| 510(k) Number | K223361 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 03, 2022 |
| Decision Date | June 10, 2023 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
BMR 1900 PHISIO
Jun 2023
Decision
219d
Days
Class 2
Risk
About This 510(k) Submission
K223361 is an FDA 510(k) clearance for the BMR 1900 PHISIO, 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 June 10, 2023, 219 days after receiving the submission on November 3, 2022. 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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