510(k) · Cleared

Cleared

HD Guide Catheter

K090335510(k) SpecialCleared May 6, 200985-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

Concentric Medical, Inc. · DQY Catheter, Percutaneous

Cleared on May 6, 2009 as substantially equivalent to K080583 (Concentric Medical, Inc., 2008) after an 85-day review. Its family tree reaches back 2 generations to 2001. 36 later devices descend from it.

Decided: May 6, 2009
Review: 85 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003880 (2001). 36 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
1 generation backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
This deviceK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
Descendant · cites it directly · 32 of its ownK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
Descendant · cites it directly · 28 of its ownK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
Descendant · cites it directly · 26 of its ownK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
Descendant · 2 generations on · 19 of its ownK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
Descendant · 2 generations on · 14 of its ownK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2011high 7 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 36 · See all

K110483Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · cites it directly32descendants
K133177Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · cites it directly28descendants
K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker · 2015 · cites it directly26descendants
K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · 2 generations on19descendants
K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker · 2019 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003880	Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022…	Concentric Medical, Inc.	2001	—
−1	K080583	Modified HD Guide Catheter	Concentric Medical, Inc.	2008	—
0 (this device)	K090335	HD Guide Catheter	Concentric Medical, Inc.	2009	—
+1	K110483	Modified HD Guide Catheter	Concentric Medical, Inc.	2011	1
+1	K133177	Modified HD Guide Catheter	Concentric Medical, Inc.	2014	3
+1	K151667	AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access…	Stryker	2015	3
+2	K180715	React 68 Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	2018	—
+2	K183463	AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access…	Stryker	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	2	0
2015	3	0
2018	2	0
2019	3	0
2020	3	0
2021	1	0
2022	2	0
2023	3	0
2024	7	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K090335, 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
*	K080583	Modified HD Guide Catheter Summary page 1 …cted blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter. Predicate Device HD Guide Catheter, K080583 Device Description The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker…	Concentric Medical, Inc.	2008	—

Also cleared against K080583: 2 other devices →

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K110483	Modified HD Guide Catheter	Concentric Medical, Inc.	2011	32
K133177	Modified HD Guide Catheter	Concentric Medical, Inc.	2014	28
K151667	AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…	Stryker	2015	26
K141981	Asahi Fubuki 043 / Asahi Fubuki	Asahi Intecc Co., Ltd.	2015	2

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 8 years and passes through 1 company; a new generation was cleared every 7.2 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K110483 (Concentric Medical, Inc., 2011) has gone furthest, with 32 descendants of its own.
2 other devices also cite its predicate K080583.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090335: HD Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090335

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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