AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T— 510(k) K013084
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K013084 for AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T, Substantially Equivalent on 2001-09-27. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code DTM
view allMore clearances from Medtronic Perfusion Systems
view all- K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) +2 more
- K181954 — autoLog IQ Autotransfusion System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.