# K123591: Flexcath Advance Steerable Sheath (12 French)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Cryocath, LP
- Decided: Dec 27, 2012 after 36 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070357 (2007). 3 ancestors in all.
13 later devices descend from it; 6 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10, Medtronic Cryocath, LP (2010) Summary page 1.

## 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
- K162925: AcQGuide Steerable Sheath (2017), 2 descendants of its own
- K211100: AcQGuide MAX Steerable Sheath (2021), 1 descendant of its own
- K183174: FlexCath Advance Steerable Sheath and Dilator (2018), 1 descendant of its own

## Indications for use
The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

Source page: https://510kreport.com/device/K123591
Methodology: https://510kreport.com/methodology