510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M

K102725510(k) TraditionalCleared May 10, 2011231-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

Bridge Medical, Inc. · DQY Catheter, Percutaneous

Cleared on May 10, 2011 as substantially equivalent to K013284 (Lumend, Inc., 2002) and 10 other predicates after a 231-day review. Its family tree reaches back 8 generations to 1989. 3 of the 65 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled once.

Decided
May 10, 2011
Review
231 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
11

Its longest line of descent runs back 8 generations to K890505 (1989). 53 ancestors in all, the oldest K884647 (1989). 11 later devices descend from it, 5 citing it directly. 3 of the 65 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 3 other ancestors2004: 4 other ancestors, 2 with a Class I recall22003: 5 other ancestors2002: 5 other ancestors2008: 1 other ancestor2006: 1 other ancestor, 1 with a Class I recall12005: 1 other ancestor1999: 3 other ancestors1997: 3 other ancestors1991: 2 other ancestors1989: 1 other ancestor2001: 4 other ancestors2000: 3 other ancestors1998: 4 other ancestors1994: 2 other ancestors1996: 2 other ancestors2014: 1 descendant cleared2012: 3 descendants cleared2020: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant clearedK890505 · Usci Grey/Black Guide Wire · C.R. Bard, Inc. · 1989K961271 · Usci Commander Series Guide Wires · C.R. Bard, Inc. · 1996K990639 · Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. · Guidant Corp. · 1999×2: 2 generations cleared close together, K022762 (2002), K031277 (2003) K041531 · Asahi Ptca Guide Wire Confianza Pro · Asahi Intecc Co., Ltd. · 2004×2: 2 generations cleared close together, K081187 (2008), K083727 (2009) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 10 other ancestors, 1 with a Class I recall13 generations back: 12 other ancestors, 1 with a Class I recall14 generations back: 5 other ancestors, 1 with a Class I recall15 generations back: 4 other ancestors6 generations back: 3 other ancestors7 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K083727 · Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012 · Bridgepoint Medical · 2009K081187 · Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001 · Bridgepoint Medical · 2008K041531 · Asahi Ptca Guide Wire Confianza Pro · Asahi Intecc Co., Ltd. · 2004K031277 · Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 · Jomed, Inc. · 2003K022762 · Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 · Jomed, Inc. · 2002K990639 · Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. · Guidant Corp. · 1999K961271 · Usci Commander Series Guide Wires · C.R. Bard, Inc. · 1996K890505 · Usci Grey/Black Guide Wire · C.R. Bard, Inc. · 1989−50
  1. Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
  2. 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
  3. 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
  4. 5 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
  5. 4 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
  6. 3 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
  7. 2 generations backK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
  8. 1 generation backK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
  9. This deviceK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011
  10. Descendant · cites it directly · 5 of its ownK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
  11. Descendant · 2 generations on · 1 of its ownK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
  12. Descendant · cites it directly · 1 of its ownK152401 Stingray LP CatheterBoston Scientific Corporation · 2015
  13. Descendant · 3 generations on · 0 of its ownK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
  14. Descendant · 2 generations on · 0 of its ownK231176 Stingray LP CatheterBoston Scientific · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 32014: 12015: 12019: 12020: 22023: 22026: 1
2012high 3 (2012) · low 0 (2013)2026

Class I recalls in this family

  • K061843 Venture Wire Control Catheter, Model WCC2 generations back · 2006
  • K042910 Venture Wire Control Catheter, Model WCC3 generations back · 2004
  • K040922 Venture Wire Control Catheter4 generations back · 2004

Most influential descendants

Showing 5 of 11 · See all
  • K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012 · cites it directly5descendants
  • K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020 · 2 generations on1descendant
  • K152401Stingray LP CatheterBoston Scientific Corporation · 2015 · cites it directly1descendant
  • K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026 · 3 generations on0descendants
  • K231176Stingray LP CatheterBoston Scientific · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K890505Usci Grey/Black Guide WireC.R. Bard, Inc.1989—
−7K961271Usci Commander Series Guide WiresC.R. Bard, Inc.1996—
−6K990639Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat…Guidant Corp.1999—
−5K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000…Jomed, Inc.2002—
−4K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc.2003—
−3K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd.2004—
−2K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire…Bridgepoint Medical2008—
−1K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical2009—
0 (this device)K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…Bridge Medical, Inc.2011—
+1K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical2012—
+2K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical2020—
+1K152401Stingray LP CatheterBoston Scientific Corporation2015—
+3K262013Kiba CTO Crossing CatheterReflow Medical, Inc.2026—
+2K231176Stingray LP CatheterBoston Scientific2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199120
199420
199620
199730
199840
199930
200030
200140
200250
200350
200442
200510
200611
200810
200930
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201410
201510
201910
202020
202320
202610
FIG. 1 — Lineage of K102725, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013284Lumend Frontrunner Cto Coronary Catheter
Summary page 1
…eration and technical aspects to the following predicate devices: Device I . ; -1 1- Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting…
Lumend, Inc.2002—
*K023223Modification to Lumend Frontrunner Cto Catheter
Summary page 1
…nd technical aspects to the following predicate devices: Device I . ; -1 1- Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon…
Lumend, Inc.2002—
*K023114Lumend Frontrunner Cto Catheter
Summary page 1
…cal aspects to the following predicate devices: Device I . ; -1 1- Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter…
Lumend, Inc.2003—
*K031005Lumend Frontrunner GW Cto CatheterLumend, Inc.2003—
*K033535Lumend Frontrunner Cto Catheter and Accessories
Summary page 1
…g predicate devices: Device I . ; -1 1- Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 St…
Lumend, Inc.2004—
*K081130Bridgepoint Medical Crossboss Percutaneous Coronary Catheter
Summary page 1
…Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and…
Bridgepoint Medical2009—
*K091841Bridgepoint Medical Crossboss Catheter, Model M-2000
Summary page 1
…Refiic.1Ok~nbK~;p~t LuMend FrontrunnerTM CTO Catheter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and K083727…
Bridgepoint Medical2009—
*K080987Bridgepoint Medical Stingray Device and Accessories
Summary page 1
…ter K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and K083727…
Bridgepoint Medical20091
*K101591Stingray Orienting Balloon Catheter
Summary page 1
…K013284, K023223, K023 114, K(03 1005, and K(033535 CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and K083727…
Bridgepoint Medical20101
*K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001
Summary page 1
…CrossBossTM Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and K083727 Page 274 of 301 =…
Bridgepoint Medical2008—
*K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012
Summary page 1
…M Catheter K081 130 and K091841 StingrayTrM Orienting Balloon Catheter K(080987 and K101591 StingrayTrm Guidewire K(081187 and K083727 Page 274 of 301 === Page 2 ==…
Bridgepoint Medical2009—

Also cleared against K013284: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125
K152401Stingray LP CatheterBoston Scientific Corporation20151
K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200
K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140
K122795Stingray GuidewiresBridgepoint Medical20120

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 26, 2012Class IIZ-2074-2012Process controlBridgePoint 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 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
  • K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
  • K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
  • 9 of the 53 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K120533 (Bridgepoint Medical, 2012) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K013284.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
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

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

Indications for use as stated in the FDA summary.

Also cleared against K013284

2 other devices cite the same predicate.

  • K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM)Ovalum, Ltd. · 2007
  • K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003

More from Bridge Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K973593Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry…Bridge Medical, Inc. · 1998

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K102725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102725

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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