510(k) · Cleared

Recalled · Class II · 2012

Bridgepoint Medical Stingray Device and Accessories

K080987510(k) TraditionalCleared Feb 6, 2009305-day reviewClass II21 CFR 870.1250Recalls 1

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

Bridgepoint Medical · DQY Catheter, Percutaneous

Cleared on Feb 6, 2009 as substantially equivalent to K011562 (Lumend, Inc., 2002) and 2 other predicates after a 305-day review. Its family tree reaches back 6 generations to 1994. 3 of the 47 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled once.

Decided: Feb 6, 2009
Review: 305 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 3

Its longest line of descent runs back 6 generations to K931794 (1994). 22 ancestors in all, the oldest K904785 (1991). 24 later devices descend from it, 4 citing it directly. 3 of the 47 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
5 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
4 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
3 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
2 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
1 generation backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
This deviceK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009
Descendant · cites it directly · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Descendant · cites it directly · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
Descendant · cites it directly · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
Descendant · cites it directly · 7 of its ownK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
Descendant · 2 generations on · 6 of its ownK120129 Mantaray CatheterBridgepoint Medical · 2012

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2010high 5 (2012) · low 0 (2013)2026

Class I recalls in this family

K061843 Venture Wire Control Catheter, Model WCCdirect predicate · 2006
K042910 Venture Wire Control Catheter, Model WCC2 generations back · 2004
K040922 Venture Wire Control Catheter3 generations back · 2004

Most influential descendants

Showing 5 of 24 · See all

K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · cites it directly14descendants
K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · cites it directly11descendants
K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · cites it directly8descendants
K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011 · cites it directly7descendants
K120129Mantaray CatheterBridgepoint Medical · 2012 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
−5	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
−4	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
−3	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I
−2	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
−1	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	Class I
0 (this device)	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	—
+1	K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	1
+1	K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…	Bridge Medical, Inc.	2011	1
+1	K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	—
+1	K111963	Bridgepoint Medical Mantaray (TM) Catheter	Bridgepoint Medical	2011	—
+2	K120129	Mantaray Catheter	Bridgepoint Medical	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	2	0
1997	1	0
1998	1	0
1999	1	0
2000	3	0
2001	3	0
2002	2	0
2003	1	0
2004	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K080987, 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
*	K011562	Lumend Percutaneous Catheter Summary page 1 …nting Balloon Catheter is substantially equivalent in intended use, method of operation and technical aspects to a combination of the following predicate devices: K01 1562- LuMend Percutaneous Catheter K061843 - Venture Wire Control Catheter Model WCC K041151 - Kerberos Occluding Guide Catheter a…	Lumend, Inc.	2002	—
*	K061843	Venture Wire Control Catheter, Model WCC Summary page 1 …quivalent in intended use, method of operation and technical aspects to a combination of the following predicate devices: K01 1562- LuMend Percutaneous Catheter K061843 - Venture Wire Control Catheter Model WCC K041151 - Kerberos Occluding Guide Catheter and Accessories Device Description:…	St Jude Medical	2006	Class I
*	K041151	Kerberos Occluding Guide Catheter and Accessories Summary page 1 …technical aspects to a combination of the following predicate devices: K01 1562- LuMend Percutaneous Catheter K061843 - Venture Wire Control Catheter Model WCC K041151 - Kerberos Occluding Guide Catheter and Accessories Device Description: The Stingray Orienting Balloon Catheter is a single…	Kerberos Proximal Solutions, Inc.	2004	—

Also cleared against K011562: 2 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	14
K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…	Bridge Medical, Inc.	2011	11
K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	8
K111963	Bridgepoint Medical Mantaray (TM) Catheter	Bridgepoint Medical	2011	7

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 26, 2012	Class II	Z-2074-2012	Process control	BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a…

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.

K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
7 of the 22 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K101591 (Bridgepoint Medical, 2010) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K011562.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BridgePoint Medical StingrayTM Orienting Balloon Catheters are indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080987 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080987: Bridgepoint Medical Stingray Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080987

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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