# K153139: Achieve ST Mapping Catheter, Catheter Connecting Cable

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 6, 2016 after 189 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 K102588 (2011). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102588: Achieve Mapping Catheter and Electrical Cable, Medtronic Ablation Frontiers, LLC (2011) Summary page 4.

## Most influential descendants
- K162892: Achieve Advance Mapping Catheter (2016), 6 descendants of its own
- 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
- K193263: Reprocessed Achieve Catheter Connecting Cable (2020), 1 descendant of its own
- K262165: FARADRIVE™ Steerable Sheath (M004PF21M402) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K153139
Methodology: https://510kreport.com/methodology