The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for En Circlr Al Adjustable Loop Mapping Catheter Models, 1045al1, 1045al2, 1060al1, 1060al2.
| Device ID | K033050 |
| 510k Number | K033050 |
| Device Name: | EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Mac Mckeen |
| Correspondent | Mac Mckeen MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-03-26 |
| Summary: | summary |