510(k) · Cleared

Cleared

Venture 038 catheter

K171335510(k) SpecialCleared Jun 7, 201730-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 7, 2017 as substantially equivalent to K040922 (Velocimed, Inc., 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1994. 2 of the 10 devices in its family, counting itself, have a Class I recall.

Decided: Jun 7, 2017
Review: 30 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K931794 (1994). 9 ancestors in all, the oldest K904785 (1991). No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
4 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
3 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
2 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
1 generation backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
This deviceK171335 Venture 038 catheterVascular Solutions, Inc. · 2017

Class I recalls in this family

K042910 Venture Wire Control Catheter, Model WCCdirect predicate · 2004
K040922 Venture Wire Control Catheterdirect predicate · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
−4	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
−3	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
−2	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I
−1	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
0 (this device)	K171335	Venture 038 catheter	Vascular Solutions, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	2	0
1997	1	0

FIG. 1 — Lineage of K171335, 1994–2017Source: 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? (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
*	K040922	Venture Wire Control Catheter Summary page 4 …Venture 038 catheter Common / Usual Name Catheter, Percutaneous Classification Name Class II Predicate Device K040922 and K042910 - 0.014” Venture Wire Control Catheter, Velocimed, Inc. Reference Device…	Velocimed, Inc.	2004	Class I
*	K042910	Venture Wire Control Catheter, Model WCC Summary page 4 …Venture 038 catheter Common / Usual Name Catheter, Percutaneous Classification Name Class II Predicate Device K040922 and K042910 - 0.014” Venture Wire Control Catheter, Velocimed, Inc. Reference Device K14…	Velocimed, Inc.	2004	Class I
†	K142065	Turnpike Catheter	Vascular Solutions, Inc.	2014	—

Also cleared against K040922: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.

K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
2 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
1 other device also cites its predicate K040922.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171335: Venture 038 catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171335

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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