Submission Details
| 510(k) Number | K181954 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 2018 |
| Decision Date | August 22, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
autoLog IQ Autotransfusion System
Aug 2018
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K181954 is an FDA 510(k) clearance for the autoLog IQ Autotransfusion System, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on August 22, 2018, 30 days after receiving the submission on July 23, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.
Device Classification
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |
Manufacturer
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