# K033050: EN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2, 1060AL1, 1060AL2

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Mar 26, 2004 after 179 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981642 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981642: Stablemapr Steerable Intracardiac Catheters, Medtronic Cardiorhythm (1998) Summary page 1.

## Indications for use
The EncircIr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.

Source page: https://510kreport.com/device/K033050
Methodology: https://510kreport.com/methodology