# K102588: Achieve Mapping Catheter and Electrical Cable

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Ablation Frontiers, LLC
- Decided: Mar 18, 2011 after 190 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) ProMap Catheter: named in the summary without a submission number
- (no number) LASSO Catheter: named in the summary without a submission number

## Most influential descendants
- K153139: Achieve ST Mapping Catheter, Catheter Connecting Cable (2016), 10 descendants of its own
- 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

## Recalls of this device
- Sep 29, 2015 · Class II · Z-0200-2016: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

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

Source page: https://510kreport.com/device/K102588
Methodology: https://510kreport.com/methodology