EasyMap MAP Catheter
MedFact Engineering GmbH
MedFact Engineering GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008497357 | 3008497357 | MedFact Engineering GmbH | 1 | N | 2026-01-01 | Hammerstr. 3 Loerrach Baden-Wurttemberg DE 79540 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164914 | 1232045802 | K151139 | EasyMap MAP Catheter | DRF | 2016-10-18 |
| 164914 | 1312262426 | ||||
| 164914 | 1994006528 | ||||
| 164914 | 2035388888 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DRF | 1 | 2016-10-18 |
PMN#
GUDID#
EasyMap MAP M (70mm) - EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the tip of the lead are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and in addition two orthogonal placed Silver Electrodes (Ag). The catheter can be introduced and positioned in the required area with the means of a suitable guiding system. The catheter has a good torque and is deflectable. By pushing the distal part of the handle the catheter tip can be deflected without jerk and infinitely variable in a steady position. The deflection of the catheter tip is effected proportional to the movement of the distal part of the handle. The once reached position then remains stable. The size of the deflection depends on the different lengths of the flexible catheter tip.
2026-01-30
EasyMap MAP L (80mm) - EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the tip of the lead are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and in addition two orthogonal placed Silver Electrodes (Ag). The catheter can be introduced and positioned in the required area with the means of a suitable guiding system. The catheter has a good torque and is deflectable. By pushing the distal part of the handle the catheter tip can be deflected without jerk and infinitely variable in a steady position. The deflection of the catheter tip is effected proportional to the movement of the distal part of the handle. The once reached position then remains stable. The size of the deflection depends on the different lengths of the flexible catheter tip.
2026-01-30
EasyMap MAP XL (90mm) - EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the tip of the lead are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and in addition two orthogonal placed Silver Electrodes (Ag). The catheter can be introduced and positioned in the required area with the means of a suitable guiding system. The catheter has a good torque and is deflectable. By pushing the distal part of the handle the catheter tip can be deflected without jerk and infinitely variable in a steady position. The deflection of the catheter tip is effected proportional to the movement of the distal part of the handle. The once reached position then remains stable. The size of the deflection depends on the different lengths of the flexible catheter tip.
2026-01-30
EasyConnect MAP Cable - EasyConnect MAP connection cables realize a safe, quick and interference-free connection of your MedFact MAP-Catheter (MagnoMap MAP and EasyMap MAP) to your EP-System. These cables are not included in the delivery of the catheter and must be ordered separately. On the catheter side the cable has a quadropolare REDEL connector; on the EP-System side four 2mm shrouded pin connectors. For EP-Systems that are not yet equipped for shrouded pins acceptance 2mm pin connectors EasyConnect Pin or screw-in connectors EasyConnect Screw are available.
2026-01-30