# 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

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 22, 2023 after 91 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K070357 (2007). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123591: Flexcath Advance Steerable Sheath (12 French), Medtronic Cryocath, LP (2012) Summary page 6.
- K162892: Achieve Advance Mapping Catheter, Medtronic, Inc. (2016) Summary page 6.

## Most influential descendants
- 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

## Recalls of this device
- Feb 12, 2024 · Class I · Z-1302-2024: Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the

## Indications for use
The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional. The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional. The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional. NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated. The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.

Source page: https://510kreport.com/device/K223824
Methodology: https://510kreport.com/methodology