510(k) · Cleared
ClearedHeartLight Deflectable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiofocus, Inc. · DRA Catheter, Steerable
Cleared on Feb 24, 2016 as substantially equivalent to K123591 (Medtronic Cryocath, LP, 2012) after a 194-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 24, 2016
- Review
- 194 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070357 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 3 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 2 generations backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- 1 generation backK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- This deviceK152310 HeartLight Deflectable SheathCardiofocus, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −3 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −2 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| −1 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| 0 (this device) | K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016 | — |
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.
Planning a device in DRA? 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 |
|---|---|---|---|
| * | K123591 | Flexcath Advance Steerable Sheath (12 French)Summary page 4…DRA, DYB Predicate Device(s): FlexCath® Advance™ Steerable Sheath & Dilator, Model 4FC12 (K123591) Reference Device(s): HeartSpan® Steerable Introducer, Models FST-085-00… | 2012 |
| † | K132164 | Heartspan Steerable Introducer Kit | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 5 other devices also cite its predicate K123591.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CardioFocus Deflectable Sheath is indicated 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/K152310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152310: HeartLight Deflectable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152310
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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