510(k) · Cleared
Recalled · 2008Convoy Advanced Delivery Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DYB Introducer, Catheter
Cleared on Mar 7, 2008 as substantially equivalent to K013866 (Boston Scientific, 2001) and 2 other predicates after a 164-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it. It has been recalled once.
- Decided
- Mar 7, 2008
- Review
- 164 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K964518 (1997). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 2 generations backK022067 Convoy Advanced Delivery SheathBoston Scientific · 2002 · Recalled
- 1 generation backK034061 Modification to Convoy Advanced Delivery SheathBoston Scientific Corp · 2004 · Recalled
- This deviceK072719 Convoy Advanced Delivery SheathBoston Scientific Corp · 2008
- Descendant · cites it directly · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · cites it directly8descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −2 | K022067 | Convoy Advanced Delivery Sheath | Boston Scientific | 2002 | 1 |
| −1 | K034061 | Modification to Convoy Advanced Delivery Sheath | Boston Scientific Corp | 2004 | 1 |
| 0 (this device) | K072719 | Convoy Advanced Delivery Sheath | Boston Scientific Corp | 2008 | — |
| +1 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 30 |
| +2 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +3 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +4 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +5 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K013866 | Convoy Advanced Delivery Sheath KitSummary page 2…of the Predicate Device The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively. The Convoy A… | 2001 |
| * | K022067 | Convoy Advanced Delivery SheathSummary page 2…edicate Device The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively. The Convoy Advanced D… | 2002 |
| * | K034061 | Modification to Convoy Advanced Delivery SheathSummary page 2…e The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively. The Convoy Advanced Delivery Sheat… | 2004 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K101497 (Oscor, Inc., 2010) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072719: Convoy Advanced Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072719
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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