Map-it Diagnostic Mapping Catheters
ACCESS POINT TECHNOLOGIES EP, INC.
ACCESS POINT TECHNOLOGIES, EP INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005402529 | 3005402529 | ACCESS POINT TECHNOLOGIES, EP INC. | 1 | N | 2026-01-01 | 12560 FLETCHER LANE SUITE 300 Rogers MN US 55374 |
| 3005402529 | 3005402529 | ACCESS POINT TECHNOLOGIES, EP INC. | 1 | N | 2020-04-25 | 12560 FLETCHER LANE SUITE 300 Rogers MN US 55374 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 337420 | 1393986977 | K250590 | MAGiC Sweep™ EP Mapping Catheter | DRF | 2025-07-23 |
| 337420 | 1115905998 | K160390 | Map-it Diagnostic Mapping Catheters | DRF | 2016-04-11 |
| 199837 | 1966948675 | K160390 | Map-it Diagnostic Mapping Catheters | DRF | 2016-04-11 |
| 199837 | 1998201112 | ||||
| 337420 | 1179680976 | ||||
| 337420 | 1639298584 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DRF | 3 | 2025-07-23 |
PMN#
GUDID#
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 13-5-0-5-5mm, 130cm
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-5-5-5-5mm, 130cm
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-13-0-5-5mm, 130cm
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-16-2-2-16mm, 130cm
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 13-2-10-13-2mm, 130cm
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-5-2mm, 0-5-5-5-5mm, 130cm
2026-05-15
Map-iT - Fixed, 10 electrode, S, 2-8-2mm electrode spacing, Guidewire Tip
2019-06-25
Map-iT - STR, 4 electrode, MPD-DL, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-S, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-S, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-SL, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-SL, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 2-5-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-L, 2-5-2mm electrode spacing
2019-06-25
Map-iT - STR 4 electrode, MPD-CS-L, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-L, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 2-5-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2-5-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 5mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-S, 2mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-M, 2-8-2-8-2-8-2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-M, 5mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-L, 2-8-2-8-2-8-2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-S, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-M, 5mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-L, 2-8-2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-L, 2mm electrode spacing
2019-06-25
Map-iT - STR, 4 electrode, MPD-CS-L, 5mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-S, 2-5-2-5-2-5-2-5-2mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-S, 2mm electrode spacing
2019-06-25
Map-iT - STR, 10 electrode, MPD-CS-L, 2mm electrode spacing
2019-06-25