510(k) · Cleared
ClearedFARADRIVE™ Steerable Sheath (M004PF21M402)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRA Catheter, Steerable
Cleared on Jul 24, 2026 as substantially equivalent to K233248 (Boston Scientific Corporation, 2023) after a 28-day review. Its family tree reaches back 6 generations to 2007. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 24, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K070357 (2007). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 5 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 4 generations backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- 3 generations backK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- 2 generations backK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023 · Recalled (Class I)
- 1 generation backK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- This deviceK262165 FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
Class I recalls in this family
- K223824 POLARSHEATH™ Steerable Sheath 12F…2 generations back · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −5 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −4 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| −3 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| −2 | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | Class I |
| −1 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| 0 (this device) | K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 2 | 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.
1 device in this family has 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 K233248 FARADRIVE™ Steerable Sheathscore 11.7 · 5 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 |
|---|---|---|---|
| * | K233248 | FARADRIVE™ Steerable SheathSummary page 6…Page 6 === Classification Regulations: 21 CFR 870.1280 Predicate Device Information: FARADRIVE™ Steerable Sheath Manufacturer: Boston Scientific Corporation 510(k) #: K233248 FDA Clearance Date: December 11th, 2023, Product Code: DRA Device Description: The FARADRIVE™ Steerable Sheath is used to facil… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 2023 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K233248.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 FARADRIVE Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262165: FARADRIVE™ Steerable Sheath (M004PF21M402).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262165
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026