510(k) · Cleared

Recalled · 2008

Convoy Advanced Delivery Sheath

K022067510(k) TraditionalCleared Sep 11, 200278-day reviewClass I21 CFR 866.5520Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific · DBY Fab, Rhodamine, Antigen, Antiserum, Control

Cleared on Sep 11, 2002 as substantially equivalent to K964518 (Daig Corp., 1997) after a 78-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it. It has been recalled once.

Decided: Sep 11, 2002
Review: 78 days
Class: Class I
Product code: DBY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K964518 (1997). 13 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
This deviceK022067 Convoy Advanced Delivery SheathBoston Scientific · 2002
Descendant · cites it directly · 12 of its ownK034061 Modification to Convoy Advanced Delivery SheathBoston Scientific Corp · 2004 · Recalled
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

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004high 3 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all

K034061Modification to Convoy Advanced Delivery SheathBoston Scientific Corp · 2004 · cites it directly12descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964518	Fast-Cath Transseptal Catheter Introducer	Daig Corp.	1997	4
0 (this device)	K022067	Convoy Advanced Delivery Sheath	Boston Scientific	2002	—
+1	K034061	Modification to Convoy Advanced Delivery Sheath	Boston Scientific Corp	2004	1
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2009	1	0
2010	2	0
2012	1	0
2015	1	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K022067, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K964518	Fast-Cath Transseptal Catheter Introducer Summary page 2 …h ffit is intended to facilitate the intracardiac placement of interventional devices. Comparison to Predicate Devices: 510(k) Reference K964518 Current Submission Intended Use Intracardiac Placement of Same…	Daig Corp.	1997	4

Also cleared against K964518: 8 other devices →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K034061	Modification to Convoy Advanced Delivery Sheath	Boston Scientific Corp	2004	12
K072719	Convoy Advanced Delivery Sheath	Boston Scientific Corp	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K034061 (Boston Scientific Corp, 2004) has gone furthest, with 12 descendants of its own.
8 other devices also cite its predicate K964518.

How does its category compare?

All DBY devices

DBY 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

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code DBY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Convoy Advanced Delivery 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/K022067 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022067: Convoy Advanced Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022067

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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