510(k) · Cleared
ClearedStingray LP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQY Catheter, Percutaneous
Cleared on Dec 4, 2015 as substantially equivalent to K102725 (Bridge Medical, Inc., 2011) after a 101-day review. Its family tree reaches back 9 generations to 1989. 3 of the 56 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 4, 2015
- Review
- 101 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K890505 (1989). 54 ancestors in all, the oldest K884647 (1989). 1 later device descends from it, 1 citing it directly. 3 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations between
- 3 generations backK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
- 2 generations backK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
- 1 generation backK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
- This deviceK152401 Stingray LP CatheterBoston Scientific Corporation · 2015
- Descendant · cites it directly · 0 of its ownK231176 Stingray LP CatheterBoston Scientific · 2023
Show all 9 generations
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 7 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 6 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 5 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 4 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 3 generations backK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
- 2 generations backK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
- 1 generation backK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
- This deviceK152401 Stingray LP CatheterBoston Scientific Corporation · 2015
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K231176Stingray LP CatheterBoston Scientific · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −8 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −7 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −6 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −5 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −4 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −3 | K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire… | Bridgepoint Medical | 2008 | — |
| −2 | K083727 | Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012 | Bridgepoint Medical | 2009 | — |
| −1 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model… | Bridge Medical, Inc. | 2011 | 1 |
| 0 (this device) | K152401 | Stingray LP Catheter | Boston Scientific Corporation | 2015 | — |
| +1 | K231176 | Stingray LP Catheter | Boston Scientific | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Summary page 4…n Name Percutaneous Catheter Product Code DQY Classification Class II, 21 CFR Part 870.1250 Predicate BridgePoint Medical K102725 May 10, 2011 Device Stingray ™ Orienting Balloon Catheter The Stingray LP Catheter facilit… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231176 | Stingray LP Catheter | 2023 | 0 |
Has anything in its family been recalled? (3 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.
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K231176 (Boston Scientific, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K102725.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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 Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.
When used as part of the system consisting of the CrossBoss Catheter, Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
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/K152401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152401: Stingray LP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152401
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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