# Medtronic Cryocath, LP

- Location (FDA's records): Mounds View, MN
- FDA decisions: 8 (2003–2020): 6 510(k) clearances and 2 original PMA approvals
- Product codes: DRA (4), DYB (2), LPB (1), OAE (1)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 11 (5 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Cryocath Technologies, Inc.: 1 (https://510kreport.com/company/cryocath-technologies)

## Firms that cite its devices most
- Acutus Medical, Inc.: 1 (https://510kreport.com/company/acutus-medical)
- Great Batch Medical: 1 (https://510kreport.com/company/great-batch-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Oscor, Inc.: 1 (https://510kreport.com/company/oscor)
- Freudenberg Medical, LLC: 1 (https://510kreport.com/company/freudenberg-medical)
- Cardiofocus, Inc.: 1 (https://510kreport.com/company/cardiofocus)

## Its most-cited devices
- K123591: Flexcath Advance Steerable Sheath (12 French) (2012), cited by 6
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10 (2010), cited by 3
- K142684: FlexCath Select Steerable Sheath (10 French) (2014), cited by 1
- K183174: FlexCath Advance Steerable Sheath and Dilator (2018), cited by 1

## Recent decisions
- K202620: FlexCath Advance Steerable Sheath and Dilator (Nov 13, 2020)
- K183174: FlexCath Advance Steerable Sheath and Dilator (Nov 26, 2018)
- K163268: FlexCath Select Steerable Shealth and Dilator (Feb 2, 2017)
- K142684: FlexCath Select Steerable Sheath (10 French) (Nov 6, 2014)
- K123591: Flexcath Advance Steerable Sheath (12 French) (Dec 27, 2012)
- P100010: Arctic Front Cryocatheter System (Dec 17, 2010)
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10 (Sep 1, 2010)
- P020045: 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System (Apr 17, 2003)

Source page: https://510kreport.com/company/medtronic-cryocath