510(k) · Cleared

Cleared

Envoy Guiding Catheter

K140307510(k) SpecialCleared Apr 21, 201473-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 21, 2014 as substantially equivalent to K093184 (Codman & Shurtleff, Inc., 2009) after a 73-day review. Its family tree reaches back 1 generation to 2009. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Apr 21, 2014
Review: 73 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K093184 (2009). 1 later device descends from it, 1 citing it directly. 1 of the 3 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 deviceK140307 Envoy Guiding CatheterCodman & Shurtleff, Inc. · 2014
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)

Class I recalls in this family

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

Most influential descendants

Showing 1 of 1 · See all

K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL · 2020 · cites it directly0descendants

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)	K140307	Envoy Guiding Catheter	Codman & Shurtleff, Inc.	2014	—
+1	K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA…	Medos International SARL	2020	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	1

FIG. 1 — Lineage of K140307, 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? (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
*	K093184	Envoy Guiding Catheters Summary page 1 …Design Peiae 11/06/2009 ENVOYT Guiding Catheters Codruan & Shurtleft. Inc. DQY Manuturing K093 184Mauatrn sterilizati…	Codman & Shurtleff, Inc.	2009	—

Also cleared against K093184: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
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?

Its one ancestor has no recall.
Of its descendants, K192804 (Medos International SARL, 2020) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K093184.

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® 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/K140307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140307: Envoy Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140307

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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