510(k) · Cleared

Cleared

Envoy Guiding Catheter

K965247510(k) TraditionalCleared Jul 23, 1997211-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

Cordis Neurovascular, Inc. · DQY Catheter, Percutaneous

Cleared on Jul 23, 1997 as substantially equivalent to K962362 (Cordis Corp., 1996) and 1 other predicate after a 211-day review. Its family tree reaches back 1 generation to 1993.

Decided: Jul 23, 1997
Review: 211 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K925131 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK925131 Cordis 9 F Guiding CatheterCordis Corp. · 1993
This deviceK965247 Envoy Guiding CatheterCordis Neurovascular, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925131	Cordis 9 F Guiding Catheter	Cordis Corp.	1993	—
0 (this device)	K965247	Envoy Guiding Catheter	Cordis Neurovascular, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K965247, 1993–1997Source: 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 DQY? 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
*	K962362	Cordis Envoy & Vista Brite Tip Guiding Catheters Summary page 1 …y Name: ENVOY® Guiding Catheter Name of Predicate Device: a) Trade Name: 5F & 6F ENVOY Guiding Catheters Manufacturer: Cordis Endovascular Systems, Inc. 510(k) Number: K962362 - concurrence 08/08/96 Predicate for design, intended use, sterilization and packaging b) Trade Name: 9F Brite Tip Guiding Cathe…	Cordis Corp.	1996	—
*	K925131	Cordis 9 F Guiding Catheter Summary page 1 …ce 08/08/96 Predicate for design, intended use, sterilization and packaging b) Trade Name: 9F Brite Tip Guiding Catheter Manufacturer: Cordis Corporation 510(k) Number: K925131 - concurrence 05/06/93 Predicate for design Classification: Class I, Catheter, Percutaneous, 21 CFR 870.1250 (74DQY) Performance…	Cordis Corp.	1993	—

Also cleared against K962362: 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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K962362.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K965247 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965247: Envoy Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965247

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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