510(k) · Cleared

Cleared

Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima

K140641510(k) TraditionalCleared Jul 3, 2014113-day reviewClass II21 CFR 870.1340

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

Boston Scientific Corporation · DYB Introducer, Catheter

Cleared on Jul 3, 2014 as substantially equivalent to K081045 (Terumo Medical Corp., 2008) after a 113-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jul 3, 2014
Review: 113 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K924607 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
2 generations backK012854 Renal Guiding SheathTerumo Medical Corp. · 2001 · Recalled
1 generation backK081045 Destination Renal Guiding SheathTerumo Medical Corp. · 2008
This deviceK140641 Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set	Arrow Intl., Inc.	1993	3
−2	K012854	Renal Guiding Sheath	Terumo Medical Corp.	2001	2
−1	K081045	Destination Renal Guiding Sheath	Terumo Medical Corp.	2008	—
0 (this device)	K140641	Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima	Boston Scientific Corporation	2014	—

FIG. 1 — Lineage of K140641, 1993–2014Source: 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 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

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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
*	K081045	Destination Renal Guiding Sheath Summary page 1 …ame Common Name Guide Sheath /Product Code DYE Classification Class 11, 21 CFR Part 870.1340 Predicate Terumo Destination Renal Guiding K081045 May 28. 2008 Device Sheath Vessix'Tm Guide Sheath isa 7F guide sheath designed to perform a…	Terumo Medical Corp.	2008	—

Also cleared against K081045: 2 other devices →

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 21 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
2 of the 3 ancestors have a recall of any class.
2 other devices also cite its predicate K081045.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)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 Vessixm Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140641 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140641: Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140641

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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