510(k) · Cleared

Cleared

Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length)

K013635510(k) TraditionalCleared Feb 11, 200298-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bacchus Vascular, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on Feb 11, 2002 as substantially equivalent to K932616 (Scimed Life Systems, Inc., 1993) and 3 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1990. 2 of the 83 devices in its family, counting itself, have a Class I recall. 75 later devices descend from it.

Decided: Feb 11, 2002
Review: 98 days
Class: Class II
Product code: QEY
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K904788 (1990). 7 ancestors in all. 75 later devices descend from it, 5 citing it directly. 2 of the 83 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
2 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
1 generation backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
This deviceK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
Descendant · cites it directly · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
Descendant · cites it directly · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
Descendant · 2 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
Descendant · 3 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
Descendant · 4 generations on · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2002high 9 (2005) · low 0 (2009)2026

Class I recalls in this family

K071664 Trellis-6 Peripheral Infusion System4 generations on · 2007
K130904 Trellis-8 Peripheral Infusion System4 generations on · 2013

Most influential descendants

Showing 5 of 75 · See all

K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · cites it directly57descendants
K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · cites it directly56descendants
K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on50descendants
K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 3 generations on46descendants
K041629Lysus Infusion SystemEkos Corp. · 2004 · 4 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K904788	Mewissen Catheter	Boston Scientific Corp	1990	—
−2	K974067	Fountain Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1998	23
−1	K981417	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	1998	—
0 (this device)	K013635	Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…	Bacchus Vascular, Inc.	2002	—
+1	K021958	Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…	Bacchus Vascular, Inc.	2002	1
+1	K023514	Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…	Bacchus Vascular, Inc.	2002	1
+2	K030637	Ekos Peripheral Infusion System	Ekos Corp.	2003	—
+3	K033214	Ekos Peripheral Infusion System	Ekos Corp.	2003	—
+4	K041629	Lysus Infusion System	Ekos Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0
1995	1	0
1996	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K013635, 1990–2026Source: 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 QEY device

#1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 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? (4)

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
*	K932616	Scimed (R) Dispatch (TM) Coronary Infusion Catheter Summary page 5 …and selective infusion of physician- specified fluids, including thrombolytics, into the peripheral vasculature. Predicate Devices Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED Life Systems, Inc. Pulse*Spray Infusion System K950907 Manufactured by AngioDynamics ISOLATE Infusion S…	Scimed Life Systems, Inc.	1993	—
*	K950907	PulseSpray Infusion System Summary page 5 …, into the peripheral vasculature. Predicate Devices Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED Life Systems, Inc. PulseSpray Infusion System K950907 Manufactured by AngioDynamics ISOLATE Infusion System K913517 Manufactured by Lake Region, Inc. Squirt™ Fluid Delivery System K…	Angiodynamics, Div. E-Z-Em, Inc.	1995	—
*	K913517	Isolate Infusion Cathetr System Summary page 5 …Coronary Infusion Catheter K932616 Manufactured by SCIMED Life Systems, Inc. Pulse*Spray Infusion System K950907 Manufactured by AngioDynamics ISOLATE Infusion System K913517 Manufactured by Lake Region, Inc. Squirt™ Fluid Delivery System K981417 Manufactured by Merit Medical Device Description The Tr…	Lake Region Mfg., Inc.	1991	—
*	K981417	Squirt Fluid Delivery System Summary page 5 …Inc. Pulse*Spray Infusion System K950907 Manufactured by AngioDynamics ISOLATE Infusion System K913517 Manufactured by Lake Region, Inc. Squirt™ Fluid Delivery System K981417 Manufactured by Merit Medical Device Description The Trellis Infusion Catheter enables the physician to isolate a treatment regi…	Merit Medical Systems, Inc.	1998	—

Also cleared against K932616: 5 other devices →

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K021958	Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…	Bacchus Vascular, Inc.	2002	57
K023514	Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)	Bacchus Vascular, Inc.	2002	56
K141617	Cleaner Rotational Thrombectomy System	Rex Medical, L.P.	2014	7
K071468	Clarivein Catheter	Vascular Insights, LLC	2008	4
K041517	Infusioncath	Id, LLC	2004	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.

K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
2 of the 7 ancestors have a recall of any class.
Of its descendants, K021958 (Bacchus Vascular, Inc., 2002) has gone furthest, with 57 descendants of its own.
5 other devices also cite its predicate K932616.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEY

1in 2024

2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007high 158 (2020) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEY

1in 2023

2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEY

5in 2025

2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEY, 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	5	28	0	0
2008	4	54	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	1	—	0	0
2015	1	—	0	0
2016	2	—	0	0
2017	3	144	0	0
2018	1	—	0	0
2019	5	91	0	0
2020	3	158	0	0
2021	3	62	0	0
2022	1	—	1	0
2023	2	—	1	1
2024	1	—	0	1
2025	0	—	0	5
2026	2	—	0	—

What is it indicated for?

The Trellis™ Infusion System is intended for controlled and selective infusion of physician-specified fluids, including

thrombolytics, into the peripheral vasculature.

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/K013635 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013635

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026