# K162892: Achieve Advance Mapping Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Nov 15, 2016 after 29 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: 2 generations back to K102588 (2011). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153139: Achieve ST Mapping Catheter, Catheter Connecting Cable, Medtronic, Inc. (2016) Summary page 4.

## Most influential descendants
- K223824: POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor (2023), 3 descendants of its own
- K233248: FARADRIVE™ Steerable Sheath (2023), 2 descendants of its own
- K262165: FARADRIVE™ Steerable Sheath (M004PF21M402) (2026), 0 descendants of its own
- K250529: Globe Introducer (601-01001) (2025), 0 descendants of its own
- K233900: Nordica PV Cryo Mapping Catheter (2024), 0 descendants of its own

## Indications for use
The Achieve Advance mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Advance mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Source page: https://510kreport.com/device/K162892
Methodology: https://510kreport.com/methodology