510(k) · Cleared
ClearedBigboss Catheters Mantatay Catheter Mantaray Guidewires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridgepoint Medical · PDU Catheter For Crossing Total Occlusions
Cleared on May 22, 2012 as substantially equivalent to K102725 (Bridge Medical, Inc., 2011) and 4 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1994. 3 of the 64 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- May 22, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K931794 (1994). 58 ancestors in all, the oldest K884647 (1989). 5 later devices descend from it, 4 citing it directly. 3 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 6 generations between
- 3 generations backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- 2 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- 1 generation backK120129 Mantaray CatheterBridgepoint Medical · 2012
- This deviceK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- Descendant · cites it directly · 1 of its ownK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- Descendant · 2 generations on · 0 of its ownK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK221163 Tunnel Crossing CatheterTractus Vascular, LLC · 2023
- Descendant · cites it directly · 0 of its ownK183357 XableCath Crossing CatheterXablecath, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK121745 Mantaray GuidewiresBridgepoint Medical · 2012
Show all 10 generations
- Root · 10 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 9 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- 8 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- 7 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- 6 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- 5 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- 4 generations backK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- 3 generations backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- 2 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- 1 generation backK120129 Mantaray CatheterBridgepoint Medical · 2012
- This deviceK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020 · cites it directly1descendant
- K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026 · 2 generations on0descendants
- K221163Tunnel Crossing CatheterTractus Vascular, LLC · 2023 · cites it directly0descendants
- K183357XableCath Crossing CatheterXablecath, Inc. · 2019 · cites it directly0descendants
- K121745Mantaray GuidewiresBridgepoint Medical · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −9 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| −8 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| −7 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| −6 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| −5 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| −4 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| −3 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
| −2 | K111963 | Bridgepoint Medical Mantaray (TM) Catheter | Bridgepoint Medical | 2011 | — |
| −1 | K120129 | Mantaray Catheter | Bridgepoint Medical | 2012 | — |
| 0 (this device) | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
| +1 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | — |
| +2 | K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | 2026 | — |
| +1 | K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023 | — |
| +1 | K183357 | XableCath Crossing Catheter | Xablecath, Inc. | 2019 | — |
| +1 | K121745 | Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 1…ded use and/or method of operation and technical aspects to the following predicate devices: ‘Device. LA > -)-i | Reference 510(k) Number BridgePoint Medical (Coronary) K102725 System (comprised of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) BigBoss™ Catheters… | 2011 |
| * | K113589 | Bigboss CatheterSummary page 1…BridgePoint Medical (Coronary) K102725 System (comprised of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) BigBoss™ Catheters K113589 Mantaray™ Catheters K111963 and K120129 Mantaray™ Guidewires K111488 : Page 16 of 2245 HAY 2 2 o BridgePoint Me… | 2012 |
| * | K111963 | Bridgepoint Medical Mantaray (TM) CatheterSummary page 1…ry) K102725 System (comprised of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) BigBoss™ Catheters K113589 Mantaray™ Catheters K111963 and K120129 Mantaray™ Guidewires K111488 : Page 16 of 2245 HAY 2 2 o BridgePoint Medical Peripheral System 510(… | 2011 |
| * | K120129 | Mantaray CatheterSummary page 1…System (comprised of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) BigBoss™ Catheters K113589 Mantaray™ Catheters K111963 and K120129 Mantaray™ Guidewires K111488 : Page 16 of 2245 HAY 2 2 o BridgePoint Medical Peripheral System 510(k) Device D… | 2012 |
| * | K111488 | Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003Summary page 1…ssBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) BigBoss™ Catheters K113589 Mantaray™ Catheters K111963 and K120129 Mantaray™ Guidewires K111488 : Page 16 of 2245 HAY 2 2 o BridgePoint Medical Peripheral System 510(k) Device Description: ' The BigBoss™ C… | 2011 |
What descends from it? (5)
4 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 58 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K193596 (Reflow Medical, 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102725.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
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/K120533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120533
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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