PMA · Approved
Recalled · 2011Arctic Front Cryocatheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cryocath, LP · OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approved on Dec 17, 2010 through premarket approval, which rests on the device’s own clinical evidence after a 280-day review. It has been recalled once.
- Decided
- Dec 17, 2010
- Review
- 280 days
- Class
- Class III
- Product code
- OAE
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100010 has 151 supplements since 2011: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2011 | 11 |
| 2012 | 9 |
| 2013 | 10 |
| 2014 | 14 |
| 2015 | 5 |
| 2016 | 7 |
| 2017 | 10 |
| 2018 | 16 |
| 2019 | 13 |
| 2020 | 12 |
| 2021 | 12 |
| 2022 | 10 |
| 2023 | 10 |
| 2024 | 7 |
| 2025 | 2 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2011 | Not classified | Z-0149-2012 | Employee error | Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributed with incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571, 25375, 25376, 25377… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OAE devicesOAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OAE
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAE
Too few OAE 510(k)s in any year since 2007 to give a median.
Recalls per year · OAE
5in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · OAE
1,412in 2025
MAUDE reports naming product code OAE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 5 | 0 |
| 2011 | 14 | — | 1 | 69 |
| 2012 | 10 | — | 0 | 70 |
| 2013 | 10 | — | 0 | 111 |
| 2014 | 15 | — | 0 | 131 |
| 2015 | 15 | — | 0 | 274 |
| 2016 | 19 | — | 0 | 311 |
| 2017 | 15 | — | 0 | 387 |
| 2018 | 28 | — | 0 | 884 |
| 2019 | 34 | — | 1 | 908 |
| 2020 | 27 | — | 0 | 744 |
| 2021 | 31 | — | 0 | 914 |
| 2022 | 26 | — | 2 | 1,161 |
| 2023 | 43 | — | 1 | 1,311 |
| 2024 | 32 | — | 7 (7) | 2,098 |
| 2025 | 20 | — | 5 (5) | 1,412 |
| 2026 | 25 | — | 0 | — |
https://510kreport.com/device/P100010 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100010: Arctic Front Cryocatheter System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100010
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026