510(k) Report

FDA applicant

Medtronic Cryocath, LP

Mounds View, MN8 decisions2003–20205 recalls

FDA records 8 decisions for Medtronic Cryocath, LP (Mounds View, MN) from 2003 to 2020: 6 510(k) clearances and 2 original PMA approvals. Most are in product codes DRA (Catheter, Steerable) and DYB (Introducer, Catheter). Its devices cite 7 predicates, 5 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronic Cryocath, LP’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 22012: 12014: 12017: 12018: 12020: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2015

2011: 22015: 2, 1 Class I
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Cryocath, LP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Cryocath, LP’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRACatheter, Steerable4decisions
  • DYBIntroducer, Catheter2decisions
  • LPBCardiac Ablation Percutaneous Catheter1decision
  • OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation1decision

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 20126cite it
  • K102176Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10Medtronic Cryocath, LP · 20103cite it
  • K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP · 20141cites it
  • K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP · 20181cites it

What has FDA decided for it lately?

  • K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP · 2020
  • K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP · 2018
  • K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP · 2017
  • K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP · 20141 Class I recall
  • K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
  • P100010Arctic Front Cryocatheter SystemMedtronic Cryocath, LP · 20101 recall
  • K102176Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10Medtronic Cryocath, LP · 20101 recall
  • P0200457F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole SystemMedtronic Cryocath, LP · 20032 recalls

All 8 as Medtronic Cryocath, LP →

What has been recalled?

5 recalls linked to its devices; the latest:

  • P020045Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac…Sep 1, 2015Class II
  • K142684Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable…Feb 23, 2015Class I
  • P100010Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec…Aug 29, 2011
  • K102176Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a…Jul 15, 2011
  • P0200457F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.Aug 4, 2006