510(k) · Cleared

Cleared

Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017

K991059510(k) TraditionalCleared Nov 16, 1999231-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

Spectranetics Corp. · DQY Catheter, Percutaneous

Cleared on Nov 16, 1999 as substantially equivalent to K935425 (Medtronics Interventional Vascular, 1994) after a 231-day review. Its family tree reaches back 1 generation to 1994. 1 of the 167 devices in its family, counting itself, has a Class I recall. 165 later devices descend from it.

Decided: Nov 16, 1999
Review: 231 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935425 (1994). 165 later devices descend from it, 7 citing it directly. 1 of the 167 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
This deviceK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
Descendant · cites it directly · 108 of its ownK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
Descendant · cites it directly · 106 of its ownK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
Descendant · 2 generations on · 80 of its ownK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
Descendant · cites it directly · 72 of its ownK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
Descendant · 2 generations on · 69 of its ownK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003

Showing 5 of 165 descendants. See all descendants

Descendants cleared per year

2002high 14 (2012) · low 1 (2006)2026

Class I recalls in this family

K141547 Wingman Extendable Tip Support Catheter5 generations on · 2014

Most influential descendants

Showing 5 of 165 · See all

K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002 · cites it directly108descendants
K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Spectranetics Corp. · 2004 · cites it directly106descendants
K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005 · 2 generations on80descendants
K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002 · cites it directly72descendants
K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003 · 2 generations on69descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935425	Metronic Buchbinder Envoy Percutaneous Catheters	Medtronics Interventional Vascular	1994	—
0 (this device)	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…	Spectranetics Corp.	1999	—
+1	K022138	Spectranetics 0.035 Support Catheter, Model 518-028	Spectranetics Corp.	2002	—
+1	K033678	Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035…	Spectranetics Corp.	2004	—
+2	K052258	Vascular Solutions Skyway Support Catheter	Vascular Solutions, Inc.	2005	—
+1	K013284	Lumend Frontrunner Cto Coronary Catheter	Lumend, Inc.	2002	—
+2	K023114	Lumend Frontrunner Cto Catheter	Lumend, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	3	0
2004	4	0
2005	4	0
2006	1	0
2007	4	0
2008	2	0
2009	7	0
2010	7	0
2011	9	0
2012	14	0
2013	4	0
2014	9	1
2015	5	0
2016	8	0
2017	14	0
2018	9	0
2019	5	0
2020	9	0
2021	9	0
2022	10	0
2023	8	0
2024	6	0
2025	7	0
2026	5	0

FIG. 1 — Lineage of K991059, 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? (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
*	K935425	Metronic Buchbinder Envoy Percutaneous Catheters Summary page 1 …n classified into Class Il. Substantial Equivalence: This product is similar in design, composition, and function to the Medtronic Buchbinder Transfer Catheters, 510(k) K935425. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990…	Medtronics Interventional Vascular	1994	—

Also cleared against K935425: 1 other device →

What descends from it? (165)

See all 165

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

Number	Device	Applicant	Decided	Descendants
K022138	Spectranetics 0.035 Support Catheter, Model 518-028	Spectranetics Corp.	2002	108
K033678	Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…	Spectranetics Corp.	2004	106
K013284	Lumend Frontrunner Cto Coronary Catheter	Lumend, Inc.	2002	72
K072750	Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066	Spectranetics Corp.	2007	66
K082337	Minnie Support Catheter	Vascular Solutions, Inc.	2009	35
K082561	Spectranetics Quick-Cross Extreme Support Catheters	Spectranetics Corp.	2008	18
K033540	Transxchange Support Catheter	Medtronic Vascular	2004	0

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.

K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K022138 (Spectranetics Corp., 2002) has gone furthest, with 108 descendants of its own.
1 other device also cites its predicate K935425.

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 Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.

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/K991059 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991059

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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