510(k) · Cleared

Cleared

Gopher Gold Catheter, Model 5620

K091345510(k) SpecialCleared Jun 12, 200937-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

Vascular Solutions, Inc. · DQY Catheter, Percutaneous

Cleared on Jun 12, 2009 as substantially equivalent to K070372 (Vascular Solutions, Inc., 2007) after a 37-day review. Its family tree reaches back 6 generations to 2000. 2 of the 36 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.

Decided: Jun 12, 2009
Review: 37 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K001992 (2000). 15 ancestors in all, the oldest K935425 (1994). 20 later devices descend from it, 4 citing it directly. 2 of the 36 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
5 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
4 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
3 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
2 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
1 generation backK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
This deviceK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
Descendant · cites it directly · 5 of its ownK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
Descendant · cites it directly · 4 of its ownK142065 Turnpike CatheterVascular Solutions, Inc. · 2014
Descendant · 2 generations on · 4 of its ownK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
Descendant · cites it directly · 4 of its ownK101659 Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM)…Vascular Solutions, Inc. · 2010 · Recalled
Descendant · cites it directly · 3 of its ownK160848 Wingman 18 Crossing CatheterReflow Medical, Inc. · 2016

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2010high 4 (2021) · low 0 (2011)2026

Class I recalls in this family

K060327 Vascular Solutions Twin-Pass Dual Access…2 generations back · 2006
K141547 Wingman Extendable Tip Support Catheter4 generations on · 2014

Most influential descendants

Showing 5 of 20 · See all

K101479Wingman Extendable Tip Support CatheterReflow Medical · 2010 · cites it directly5descendants
K142065Turnpike CatheterVascular Solutions, Inc. · 2014 · cites it directly4descendants
K120178Wingman Extendable Tip Support CatheterReflow Medical · 2012 · 2 generations on4descendants
K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc. · 2010 · cites it directly4descendants
K160848Wingman 18 Crossing CatheterReflow Medical, Inc. · 2016 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K001992	Ilt 0.014 Catheter, Model C114NL2	Intra Luminal Therapeutics, Inc.	2000	—
−5	K012169	Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing…	Intra Luminal Therapeutics, Inc.	2001	—
−4	K030984	Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14…	Intra Luminal Therapeutics, Inc.	2003	—
−3	K032660	Xtrak Support Catheter	Xtrak Medical, Inc.	2003	—
−2	K051772	Asahi Tornus Support Catheter	Asahi Intecc Co., Ltd.	2005	—
−1	K070372	Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model…	Vascular Solutions, Inc.	2007	—
0 (this device)	K091345	Gopher Gold Catheter, Model 5620	Vascular Solutions, Inc.	2009	—
+1	K101479	Wingman Extendable Tip Support Catheter	Reflow Medical	2010	—
+1	K142065	Turnpike Catheter	Vascular Solutions, Inc.	2014	—
+2	K120178	Wingman Extendable Tip Support Catheter	Reflow Medical	2012	—
+1	K101659	Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model…	Vascular Solutions, Inc.	2010	1
+1	K160848	Wingman 18 Crossing Catheter	Reflow Medical, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1999	1	0
2000	2	0
2002	2	0
2004	1	0
2005	1	0
2006	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2012	2	0
2013	1	0
2014	2	1
2015	2	0
2016	1	0
2017	1	0
2018	1	0
2019	2	0
2021	4	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K091345, 2000–2026Source: 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.

2 devices in this family have 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

Get a 510(k) Report

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
*	K070372	Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 Summary page 1 …Gold catheter Common / Usual Name Percutaneous catheter Classification Name 870.1250 Catheter, percutaneous Predicate Device K070372 Gopher catheter (Vascular Solutions, Inc.) Device Description The Gopher Gold catheter is a 3F catheter that is compatible wit…	Vascular Solutions, Inc.	2007	—

Also cleared against K070372: 2 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K101479	Wingman Extendable Tip Support Catheter	Reflow Medical	2010	5
K142065	Turnpike Catheter	Vascular Solutions, Inc.	2014	4
K101659	Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301	Vascular Solutions, Inc.	2010	4
K160848	Wingman 18 Crossing Catheter	Reflow Medical, Inc.	2016	3

Has anything in its family been recalled? (2 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.

K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
1 of the 15 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K101479 (Reflow Medical, 2010) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K070372.

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 Gopher Gold catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091345 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091345: Gopher Gold Catheter, Model 5620.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091345

Report an extraction error

Are you the manufacturer?

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