510(k) · Cleared
ClearedBridgepoint Medical Mantaray (TM) Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridgepoint Medical · DQY Catheter, Percutaneous
Cleared on Aug 10, 2011 as substantially equivalent to K080987 (Bridgepoint Medical, 2009) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 1994. 3 of the 32 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Aug 10, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931794 (1994). 24 ancestors in all, the oldest K904785 (1991). 7 later devices descend from it, 2 citing it directly. 3 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 7 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- 6 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- 5 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- 4 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- 3 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- 2 generations backK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- 1 generation backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- This deviceK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- Descendant · cites it directly · 6 of its ownK120129 Mantaray CatheterBridgepoint Medical · 2012
- Descendant · cites it directly · 5 of its ownK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- Descendant · 2 generations on · 1 of its ownK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- Descendant · 3 generations on · 0 of its ownK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221163 Tunnel Crossing CatheterTractus Vascular, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K120129Mantaray CatheterBridgepoint Medical · 2012 · cites it directly6descendants
- K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012 · cites it directly5descendants
- K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020 · 2 generations on1descendant
- K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026 · 3 generations on0descendants
- K221163Tunnel Crossing CatheterTractus Vascular, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −7 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| −6 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| −5 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| −4 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| −3 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| −2 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| −1 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
| 0 (this device) | K111963 | Bridgepoint Medical Mantaray (TM) Catheter | Bridgepoint Medical | 2011 | — |
| +1 | K120129 | Mantaray Catheter | Bridgepoint Medical | 2012 | — |
| +1 | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
| +2 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | — |
| +3 | K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | 2026 | — |
| +2 | K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K080987 | Bridgepoint Medical Stingray Device and AccessoriesSummary page 1…es: The BridgePoint Medical MantarayTM Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K080987 and K 10 1591 - StingrayTM Catheter Device Description: The MantarayTM Catheter is a single use, over-the-wire, disposable, dual… | 2009 |
| * | K101591 | Stingray Orienting Balloon CatheterSummary page 1…gePoint Medical MantarayTM Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K080987 and K 10 1591 - StingrayTM Catheter Device Description: The MantarayTM Catheter is a single use, over-the-wire, disposable, dual lumen percuta… | 2010 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 9 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K120129 (Bridgepoint Medical, 2012) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K080987.
How does its category compare?
All DQY devicesDQY 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
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 BridgePoint Medical MantarayTM Catheter is indicated for directing, steering,
controlling, and supporting a guidewire in order to access discrete regions of the
peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111963: Bridgepoint Medical Mantaray (TM) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111963
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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