510(k) · Cleared

Cleared

Spectranetics Cross-Pilot Turbo Elite Support Catheter

K082559510(k) TraditionalCleared Dec 11, 200898-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 Dec 11, 2008 as substantially equivalent to K992051 (Terumo Medical Corp., 1999) and 1 other predicate after a 98-day review. Its family tree reaches back 4 generations to 1992. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Dec 11, 2008
Review: 98 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K921310 (1992). 9 ancestors in all, the oldest K862006 (1986). 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
3 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
2 generations backK970854 5 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Recalled (Class I)
1 generation backK051561 Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005
This deviceK082559 Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008
Descendant · cites it directly · 0 of its ownK090913 Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2009

Class I recalls in this family

K970854 5 FR and 6 FR Infiniti Angiographic Catheter2 generations back · 1997

Most influential descendants

Showing 1 of 1 · See all

K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K921310	Cordis 6 French Paragon Angiographic Catheter	Cordis Corp.	1992	—
−3	K960975	1-4F Infiniti Angiographic Catheter	Cordis Corp.	1996	1
−2	K970854	5 FR and 6 FR Infiniti Angiographic Catheter	Cordis Corp.	1997	Class I
−1	K051561	Asahi Angiographic Catheter	Asahi Intecc Co., Ltd.	2005	—
0 (this device)	K082559	Spectranetics Cross-Pilot Turbo Elite Support Catheter	Spectranetics Corp.	2008	—
+1	K090913	Cross-Pilot Turbo Elite Support Catheter	Spectranetics Corp.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	2	0
1992	1	0
1993	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K082559, 1992–2009Source: 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? (2)

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
*	K992051	Radifocus Optitorque Summary page 1 …theter, Percutaneous D. Device Class: Class II (per 21 CFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Terumo 5Fr RadiFocus Optitorque (marketed as Glidecath) - K992051 Asahi Angiographic Catheters (marketed as Cook Slip-Cath XL) - K051561 DEVICE DESCRIPTION Specifications:…	Terumo Medical Corp.	1999	—
*	K051561	Asahi Angiographic Catheter Summary page 1 …Device Code: DQY CLAIMED EQUIVALENCE Terumo 5Fr RadiFocus Optitorque (marketed as Glidecath) - K992051 Asahi Angiographic Catheters (marketed as Cook Slip-Cath XL) - K051561 DEVICE DESCRIPTION Specifications: Max. (OD) *Max Model…	Asahi Intecc Co., Ltd.	2005	—

Also cleared against K992051: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090913	Cross-Pilot Turbo Elite Support Catheter	Spectranetics Corp.	2009	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.

K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K090913 (Spectranetics Corp., 2009) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K992051.

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?

Cross-Pilot Turbo Elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082559: Spectranetics Cross-Pilot Turbo Elite Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082559

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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