510(k) · Cleared

Cleared

Chaperon Guiding Catheter

K082385510(k) TraditionalCleared Dec 11, 2008114-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

MicroVention, Inc. · DQY Catheter, Percutaneous

Cleared on Dec 11, 2008 as substantially equivalent to K070970 (Penumbra, Inc., 2007) after a 114-day review. Its family tree reaches back 4 generations to 2001. 17 later devices descend from it.

Decided: Dec 11, 2008
Review: 114 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K010954 (2001). 5 ancestors in all, the oldest K010853 (2001). 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
3 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
2 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
1 generation backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
This deviceK082385 Chaperon Guiding CatheterMicroVention, Inc. · 2008
Descendant · cites it directly · 11 of its ownK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
Descendant · 2 generations on · 7 of its ownK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
Descendant · 2 generations on · 6 of its ownK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
Descendant · 3 generations on · 2 of its ownK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
Descendant · 2 generations on · 2 of its ownK182602 SOFIA EX Intracranial Support CatheterMicroVention, Inc. · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011high 3 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 17 · See all

K131482Sofia Distal Access CatheterMicroVention, Inc. · 2013 · cites it directly11descendants
K142014Sofia Distal Access CatheterMicroVention, Inc. · 2014 · 2 generations on7descendants
K150366SOFIA 6F CatheterMicroVention, Inc. · 2015 · 2 generations on6descendants
K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · 3 generations on2descendants
K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc. · 2019 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010954	Concentric Balloon Guide Catheter, Model 90031	Concentric Medical, Inc.	2001	1
−3	K021899	Concentric Balloon Guide Catheter, Model 90072	Concentric Medical, Inc.	2002	1
−2	K053491	Penumbra Balloon Guide Catheter, Model 7.5F	Penumbra, Inc.	2006	—
−1	K070970	Neuron Support Catheter System, Model 5F/6F	Penumbra, Inc.	2007	1
0 (this device)	K082385	Chaperon Guiding Catheter	MicroVention, Inc.	2008	—
+1	K131482	Sofia Distal Access Catheter	MicroVention, Inc.	2013	—
+2	K142014	Sofia Distal Access Catheter	MicroVention, Inc.	2014	—
+2	K150366	SOFIA 6F Catheter	MicroVention, Inc.	2015	—
+3	K201682	RIST Radial Access Catheter	Rist Neurovascular, Inc.	2020	—
+2	K182602	SOFIA EX Intracranial Support Catheter	MicroVention, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2019	1	0
2020	1	0
2022	2	0
2023	3	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K082385, 2001–2026Source: 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? (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
*	K070970	Neuron Support Catheter System, Model 5F/6F Summary page 1 …, California U.S.A. Contact: Florin Truuvert Predicate Device: Number Description Predicate For Clearance Date K070970 Penumbra Inc., Chaperon Guiding August 17, Neuron Intracranial Cat…	Penumbra, Inc.	2007	1

Also cleared against K070970: 8 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K131482	Sofia Distal Access Catheter	MicroVention, Inc.	2013	11
K222115	ISAAC Neurovascular Navigation Catheter	MicroVention, Inc.	2023	1
K102418	Reverse Medical Report Guide Catheter System	Reverse Medical Corporation	2011	1
K160919	Hansen Medical Magellan Robotic Catheter 9Fr	Hansen Medical, Inc.	2016	0

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 7 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
4 of the 5 ancestors have a recall of any class.
Of its descendants, K131482 (MicroVention, Inc., 2013) has gone furthest, with 11 descendants of its own.
8 other devices also cite its predicate K070970.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082385: Chaperon 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/K082385

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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