510(k) · Cleared

Recalled · Class I · 2017

Venture Wire Control Catheter

K040922510(k) TraditionalCleared Aug 18, 2004132-day reviewClass II21 CFR 870.1250Recalls 1 (1 Class I)

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

Velocimed, Inc. · DQY Catheter, Percutaneous

Cleared on Aug 18, 2004 as substantially equivalent to K012749 (Biocardia, Inc., 2002) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 1994. 3 of the 39 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Aug 18, 2004
Review: 132 days
Class: Class II
Product code: DQY
Recalls: 1 (1 Class I)
Predicates: 2

Its longest line of descent runs back 3 generations to K931794 (1994). 7 ancestors in all, the oldest K904785 (1991). 31 later devices descend from it, 2 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
2 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
1 generation backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
This deviceK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004
Descendant · cites it directly · 30 of its ownK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
Descendant · 2 generations on · 28 of its ownK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
Descendant · 3 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
Descendant · 4 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Descendant · 4 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004high 5 (2012) · low 0 (2005)2026

Class I recalls in this family

K042910 Venture Wire Control Catheter, Model WCCcites it directly · 2004
K061843 Venture Wire Control Catheter, Model WCC2 generations on · 2006

Most influential descendants

Showing 5 of 31 · See all

K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · cites it directly30descendants
K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 2 generations on28descendants
K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 3 generations on24descendants
K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 4 generations on14descendants
K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
−2	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
−1	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
0 (this device)	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	—
+1	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
+2	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	Class I
+3	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	1
+4	K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	1
+4	K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…	Bridge Medical, Inc.	2011	1

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	1
2006	1	1
2009	1	0
2010	1	0
2011	2	0
2012	5	0
2014	2	0
2015	2	0
2016	4	0
2017	3	0
2019	2	0
2020	2	0
2023	3	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K040922, 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.

3 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

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What was it cleared against? (3)

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
*	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664 Summary page 2 …equivalent to other legally marketed devices namely, IntraLuminal (K 904785) and Xtrak TOPS Catheter (K012749), Catheter Research Inc's Cynosar Catheter catheter principl…	Biocardia, Inc.	2002	—
*	K904785	Cri Cynosar Catheter Summary page 2 …Therapeutics Deflectable equivalent to other legally marketed devices namely, IntraLuminal (K 904785) and Xtrak TOPS Catheter (K012749), Catheter Research Inc's Cynosar Catheter catheter…	Catheter Research C/O Burditt, Bowles & Radzius	1991	—
*	—	Xtrak TOPS catheter Named without a submission number			—

Also cleared against K012749: 2 other devices →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K042910	Venture Wire Control Catheter, Model WCC Class I	Velocimed, Inc.	2004	30
K171335	Venture 038 catheter	Vascular Solutions, Inc.	2017	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 25, 2017	Class I	Z-2224-2017	Process control	Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation…

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 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K042910 (Velocimed, Inc., 2004) has gone furthest, with 30 descendants of its own.
2 other devices also cite its predicate K012749.

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 VentureTM Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and 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/K040922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040922: Venture Wire Control Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040922

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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