Submission Details
| 510(k) Number | K200091 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2020 |
| Decision Date | November 18, 2021 |
| Days to Decision | 672 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
Capiox iCP Centrifugal Pump
Nov 2021
Decision
672d
Days
Class 2
Risk
About This 510(k) Submission
K200091 is an FDA 510(k) clearance for the Capiox iCP Centrifugal Pump, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on November 18, 2021, 672 days after receiving the submission on January 16, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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