510(k) · Cleared
Recalled · 2008Convoy Advanced Delivery Sheath Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · DBY Fab, Rhodamine, Antigen, Antiserum, Control
Cleared on Dec 14, 2001 as substantially equivalent to K992309 (Boston Scientific Corp, 1999) after a 23-day review. Its family tree reaches back 1 generation to 1999. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 14, 2001
- Review
- 23 days
- Class
- Class I
- Product code
- DBY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992309 (1999). 12 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992309 Introducer Sheath, Vessel DilatorBoston Scientific Corp · 1999
- This deviceK013866 Convoy Advanced Delivery Sheath KitBoston Scientific · 2001
- Descendant · cites it directly · 11 of its ownK072719 Convoy Advanced Delivery SheathBoston Scientific Corp · 2008 · Recalled
- Descendant · 2 generations on · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 4 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 5 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072719Convoy Advanced Delivery SheathBoston Scientific Corp · 2008 · cites it directly11descendants
- K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · 2 generations on8descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 3 generations on7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 4 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992309 | Introducer Sheath, Vessel Dilator | Boston Scientific Corp | 1999 | — |
| 0 (this device) | K013866 | Convoy Advanced Delivery Sheath Kit | Boston Scientific | 2001 | — |
| +1 | K072719 | Convoy Advanced Delivery Sheath | Boston Scientific Corp | 2008 | 1 |
| +2 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 30 |
| +3 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +4 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +5 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
Planning a device in DBY? 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
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 |
|---|---|---|---|
| * | K992309 | Introducer Sheath, Vessel DilatorSummary page 2…ptal position after transseptal puncture has been obtained using a different sheath. Comparison to Predicate Device: Predicate Device Modified Device 510(k) Reference K992309 Current Submission Intended Use Intracardiac Placement of Same Interventional Devices Device Intracardiac Introducing Sheath ~ Sa… | 1999 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072719 | Convoy Advanced Delivery Sheath | 2008 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 24, 2008 | Not classified | Z-1072-2009 | Process design | The marker band may detach from the sheath and a clinical failure could result in an embolism. |
| Dec 24, 2008 | Not classified | Z-1071-2009 | Process design | The marker band may detach from the sheath and a clinical failure could result in an embolism. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K072719 (Boston Scientific Corp, 2008) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DBY devicesDBY Fab, Rhodamine, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBY
FDA has decided no DBY device since 2007.
Median 510(k) review, days · DBY
Too few DBY 510(k)s in any year since 2007 to give a median.
Recalls per year · DBY
No recall names DBY since 2007.
Adverse event reports per year · DBY
1in 2007
MAUDE reports naming product code DBY, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained using a different sheath.
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/K013866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013866: Convoy Advanced Delivery Sheath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026