510(k) · Cleared

Cleared

Minnie Support Catheter

K082337510(k) TraditionalCleared Jan 15, 2009154-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 Jan 15, 2009 as substantially equivalent to K991059 (Spectranetics Corp., 1999) and 5 other predicates after a 154-day review. Its family tree reaches back 5 generations to 1994. 1 of the 47 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.

Decided: Jan 15, 2009
Review: 154 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K935425 (1994). 11 ancestors in all. 35 later devices descend from it, 5 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 5 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
4 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
3 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
2 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
1 generation backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
This deviceK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
Descendant · cites it directly · 14 of its ownK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
Descendant · 2 generations on · 12 of its ownK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
Descendant · 3 generations on · 8 of its ownK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
Descendant · cites it directly · 6 of its ownK141649 Spex Support CatheterReflow Medical · 2014
Descendant · 2 generations on · 5 of its ownK173662 speX Support CatheterReflow Medical, Inc. · 2017

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2009high 6 (2017) · low 0 (2010)2026

Class I recalls in this family

K060327 Vascular Solutions Twin-Pass Dual Access…direct predicate · 2006

Most influential descendants

Showing 5 of 35 · See all

K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009 · cites it directly14descendants
K112082Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · 2 generations on12descendants
K172090GuideLiner V3 CatheterVascular Solutions, Inc. · 2017 · 3 generations on8descendants
K141649Spex Support CatheterReflow Medical · 2014 · cites it directly6descendants
K173662speX Support CatheterReflow Medical, Inc. · 2017 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K935425	Metronic Buchbinder Envoy Percutaneous Catheters	Medtronics Interventional Vascular	1994	—
−4	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…	Spectranetics Corp.	1999	—
−3	K022138	Spectranetics 0.035 Support Catheter, Model 518-028	Spectranetics Corp.	2002	—
−2	K033678	Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035…	Spectranetics Corp.	2004	—
−1	K052258	Vascular Solutions Skyway Support Catheter	Vascular Solutions, Inc.	2005	—
0 (this device)	K082337	Minnie Support Catheter	Vascular Solutions, Inc.	2009	—
+1	K091750	Guideliner Catheter, Models 5571, 5572, 5573	Vascular Solutions, Inc.	2009	—
+2	K112082	Guideliner V2 Catheter	Vascular Solutions, Inc.	2011	1
+3	K172090	GuideLiner V3 Catheter	Vascular Solutions, Inc.	2017	—
+1	K141649	Spex Support Catheter	Reflow Medical	2014	—
+2	K173662	speX Support Catheter	Reflow Medical, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	3	0
2002	1	0
2006	1	1
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2011	1	0
2012	2	0
2013	2	0
2014	2	0
2016	4	0
2017	6	0
2018	2	0
2019	1	0
2020	4	0
2021	1	0
2022	1	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K082337, 1994–2026Source: 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.

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? (6)

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
*	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support… Summary page 1 …II Classification Name: Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27…	Spectranetics Corp.	1999	—
*	K022138	Spectranetics 0.035 Support Catheter, Model 518-028 Summary page 1 …lassification Name: Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27), manufa…	Spectranetics Corp.	2002	—
*	K033678	Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036… Summary page 1 …tion Name: Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27), manufactured by…	Spectranetics Corp.	2004	—
*	K072750	Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 Summary page 1 …Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27), manufactured by Vascular S…	Spectranetics Corp.	2007	—
*	K052258	Vascular Solutions Skyway Support Catheter Summary page 1 …redicate Devices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27), manufactured by Vascular Solutions, Inc. Device Description The Minnie Support Catheter is avail…	Vascular Solutions, Inc.	2005	—
*	K060327	Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter Summary page 1 …ices Quick-Cross®b Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation. Skyway TM Support Catheter (K052258 and K0603 27), manufactured by Vascular Solutions, Inc. Device Description The Minnie Support Catheter is available in nine…	Vascular Solutions, Inc.	2006	Class I

Also cleared against K991059: 6 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K091750	Guideliner Catheter, Models 5571, 5572, 5573	Vascular Solutions, Inc.	2009	14
K141649	Spex Support Catheter	Reflow Medical	2014	6
K130714	Progigy Support Catheter	Radius Medical, LLC	2013	4
K123311	Qxmedical Access & Support Catheter	Qxmedical, LLC	2013	4
K092299	Trailblazer Support Catheter	Ev3, Inc.	2009	2

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.

K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
1 of the 11 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K091750 (Vascular Solutions, Inc., 2009) has gone furthest, with 14 descendants of its own.
6 other devices also cite its predicate K991059.

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 Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082337: Minnie Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082337

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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