510(k) · Cleared

Cleared

Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB, MPC & XB

K140080510(k) SpecialCleared Apr 24, 2014100-day reviewClass II21 CFR 870.1250

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

Codman & Shurtleff, Inc. · DQY Catheter, Percutaneous

Cleared on Apr 24, 2014 as substantially equivalent to K120229 (Codman & Shurtleff, Inc., 2012) and 1 other predicate after a 100-day review. Its family tree reaches back 1 generation to 2009. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided: Apr 24, 2014
Review: 100 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K093184 (2009). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK093184 Envoy Guiding CathetersCodman & Shurtleff, Inc. · 2009
This deviceK140080 Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM…Codman & Shurtleff, Inc. · 2014
Descendant · cites it directly · 1 of its ownK162563 YOGA MicrocatheterCodman & Shurtleff, Inc. · 2017
Descendant · cites it directly · 0 of its ownK201076 Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020
Descendant · cites it directly · 0 of its ownK192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm…Medos International SARL · 2020 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK171653 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpCodman & Shurtleff, Inc. · 2017

Class I recalls in this family

K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA…cites it directly · 2020

Most influential descendants

Showing 4 of 4 · See all

K162563YOGA MicrocatheterCodman & Shurtleff, Inc. · 2017 · cites it directly1descendant
K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020 · cites it directly0descendants
K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL · 2020 · cites it directly0descendants
K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpCodman & Shurtleff, Inc. · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K093184	Envoy Guiding Catheters	Codman & Shurtleff, Inc.	2009	—
0 (this device)	K140080	Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB…	Codman & Shurtleff, Inc.	2014	—
+1	K162563	YOGA Microcatheter	Codman & Shurtleff, Inc.	2017	—
+1	K201076	Anchor Dual Lumen Guidewire Catheter	Aqure Medical, Inc.	2020	—
+1	K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA…	Medos International SARL	2020	Class I
+2	K171653	YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up	Codman & Shurtleff, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2020	2	1

FIG. 1 — Lineage of K140080, 2009–2020Source: 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.

1 device in this family has a Class I recall. 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (2)

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
*	K120229	Envoy Distal Access Guiding Catheter Summary page 1 …Intended Use Design Predicate 0/42 ENVOY®8 Distal Access Codtman & DQY* Materials K 120229 022/02 Guiding Catheter Shurtleff Inc. Manufacturing…	Codman & Shurtleff, Inc.	2012	—
*	K093184	Envoy Guiding Catheters Summary page 4 …005) 480A PET/.002 LDPE Mteral Pouh Bottom Wet,: tUncoated l073B 48GA PET/.002 LOJPE Same as K093 184 ________________Tyvek Bottom Web: LUncoated 1073B' TYvek Carton Material…	Codman & Shurtleff, Inc.	2009	—

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K162563	YOGA Microcatheter	Codman & Shurtleff, Inc.	2017	1
K201076	Anchor Dual Lumen Guidewire Catheter	Aqure Medical, Inc.	2020	0
K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide… Class I	Medos International SARL	2020	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K162563 (Codman & Shurtleff, Inc., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQY devices

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

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral,

coronary, and neurovasculature for the intravascular introduction of

interventional/diagnostic devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140080 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140080: Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB, MPC & XB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140080

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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