510(k) · Cleared

Cleared

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

K172995510(k) TraditionalCleared Nov 21, 201755-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

Terumo Medical Corporation · DYB Introducer, Catheter

Cleared on Nov 21, 2017 as substantially equivalent to K052185 (Terumo Medical Corp., 2005) and 2 other predicates after a 55-day review. Its family tree reaches back 5 generations to 1993.

Decided: Nov 21, 2017
Review: 55 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K924607 (1993). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
4 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
3 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
2 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
1 generation backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
This deviceK172995 Destination Carotid Guiding Sheath, Destination Peripheral Guiding…Terumo Medical Corporation · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set	Arrow Intl., Inc.	1993	3
−4	K012812	Carotid Guiding Sheath	Terumo Medical Corp.	2001	1
−3	K051601	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2005	—
−2	K080415	Device Modification to Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2008	—
−1	K091329	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2009	1
0 (this device)	K172995	Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath…	Terumo Medical Corporation	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	1	0
2008	1	0

FIG. 1 — Lineage of K172995, 1993–2017Source: 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? (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	Applicant	Decided	Recalls
*	K052185	Destination Carotid Guiding Sheath Summary page 5 …fication: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed are: • Predicate Device: K052185 – Destination® Carotid Guiding Sheath, manufactured by Terumo Medical Corporation • Predicate Device: K091329 – D…	Terumo Medical Corp.	2005	1
*	K091329	Pinnacle Destination Peripheral Guiding Sheath Summary page 5 …e is claimed are: • Predicate Device: K052185 – Destination® Carotid Guiding Sheath, manufactured by Terumo Medical Corporation • Predicate Device: K091329 – Destination® Peripheral Guiding Sheath, manufactured by Terumo Medical Corporation • Predicate Device: K081045…	Terumo Medical Corp.	2009	1
*	K081045	Destination Renal Guiding Sheath Summary page 5 …al Corporation • Predicate Device: K091329 – Destination® Peripheral Guiding Sheath, manufactured by Terumo Medical Corporation • Predicate Device: K081045 – Destination® Renal Guiding Sheath, manufactured by Terumo Medical Corporation The primary predicate device is K052…	Terumo Medical Corp.	2008	—

Also cleared against K052185: 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 24 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
5 of the 8 ancestors have a recall of any class.
2 other devices also cite its predicate K052185.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172995 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172995: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172995

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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