510(k) · Cleared
ClearedFlexcath Advance Steerable Sheath (12 French)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cryocath, LP · DRA Catheter, Steerable
Cleared on Dec 27, 2012 as substantially equivalent to K102176 (Medtronic Cryocath, LP, 2010) after a 36-day review. Its family tree reaches back 3 generations to 2007. 2 of the 17 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Dec 27, 2012
- Review
- 36 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070357 (2007). 13 later devices descend from it, 6 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 2 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 1 generation backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- This deviceK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- Descendant · cites it directly · 3 of its ownK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- Descendant · cites it directly · 2 of its ownK162925 AcQGuide Steerable SheathAcutus Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK211100 AcQGuide MAX Steerable SheathAcutus Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK183174 FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation · 2023 · cites it directly3descendants
- K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · 2 generations on2descendants
- K162925AcQGuide Steerable SheathAcutus Medical, Inc. · 2017 · cites it directly2descendants
- K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc. · 2021 · 2 generations on1descendant
- K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −2 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −1 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| 0 (this device) | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| +1 | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | Class I |
| +2 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| +1 | K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017 | — |
| +2 | K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021 | — |
| +1 | K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…Summary page 1…DRA Predicate Device(s): FlexCath® Steerable Sheath & Dilator, Model 3FC 12 (K 102 176) 5.2 Device Description The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a… | 2010 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping… Class I | 2023 | 3 |
| K162925 | AcQGuide Steerable Sheath | 2017 | 2 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | 2018 | 1 |
| K142684 | FlexCath Select Steerable Sheath (10 French) Class I | 2014 | 1 |
| K192422 | Steerable Introducer 12F | 2019 | 0 |
| K152310 | HeartLight Deflectable Sheath | 2016 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K223824 (Boston Scientific Corporation, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K102176.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123591: Flexcath Advance Steerable Sheath (12 French).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123591
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026