510(k) · Cleared

Recalled · Class I · 2017

Venture Wire Control Catheter, Model WCC

K061843510(k) SpecialCleared Aug 1, 200632-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

St Jude Medical · DQY Catheter, Percutaneous

Cleared on Aug 1, 2006 as substantially equivalent to K042910 (Velocimed, Inc., 2004) after a 32-day review. Its family tree reaches back 5 generations to 1994. 3 of the 38 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Aug 1, 2006
Review: 32 days
Class: Class II
Product code: DQY
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 5 generations to K931794 (1994). 9 ancestors in all, the oldest K904785 (1991). 28 later devices descend from it, 2 citing it directly. 3 of the 38 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 deviceK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006
Descendant · cites it directly · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
Descendant · 2 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Descendant · 2 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
Descendant · 2 generations on · 7 of its ownK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2009high 5 (2012) · low 0 (2013)2026

Class I recalls in this family

K042910 Venture Wire Control Catheter, Model WCCdirect predicate · 2004
K040922 Venture Wire Control Catheter2 generations back · 2004

Most influential descendants

Showing 5 of 28 · See all

K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · cites it directly24descendants
K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 2 generations on14descendants
K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 2 generations on11descendants
K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011 · 2 generations on7descendants

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)	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	—
+1	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	1
+2	K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	1
+2	K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…	Bridge Medical, Inc.	2011	1
+2	K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	—
+2	K111963	Bridgepoint Medical Mantaray (TM) Catheter	Bridgepoint Medical	2011	—

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
2009	1	0
2010	1	0
2011	2	0
2012	5	0
2014	2	0
2015	2	0
2016	4	0
2017	2	0
2019	2	0
2020	2	0
2023	3	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K061843, 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

Get a 510(k) Report

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
*	K042910	Venture Wire Control Catheter, Model WCC Summary page 2 …eter device covered by this submission is similar in function, mechanism of action and intended use to market cleared predicate device, Venture TM Wire Control Catheter (K042910 - November 11, 2004). 6.6 TEST SUMMARY The Rapid Exchange Venture Wire Control Catheter passed all verification specificati…	Velocimed, Inc.	2004	Class I

Also cleared against K042910: 2 other devices →

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	24
K182570	Venture 0.014 Catheter	Vascular Solutions, LLC	2019	2

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 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.
Of its descendants, K080987 (Bridgepoint Medical, 2009) has gone furthest, with 24 descendants of its own.
2 other devices also cite its predicate K042910.

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 Venture TM Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061843 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061843: Venture Wire Control Catheter, Model WCC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061843

Report an extraction error

Are you the manufacturer?

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