autoLog IQ Autotransfusion System— 510(k) K181954
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K181954 for autoLog IQ Autotransfusion System, Substantially Equivalent on 2018-08-22. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code CAC
view allMore clearances from Medtronic Perfusion Systems
view all- K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) +2 more
- K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
- K080824 — BIO-CONSOLE 560
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.