510(k) · Cleared
ClearedThreader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jul 21, 2014 as substantially equivalent to K130391 (Boston Scientific Corp, 2013) and 3 other predicates after a 202-day review. Its family tree reaches back 9 generations to 1989. 3 of the 77 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 21, 2014
- Review
- 202 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K890505 (1989). 76 ancestors in all, the oldest P860019 (1986). No later device cites it as a predicate yet. 3 of the 77 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 deviceK134031 Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire…Boston Scientific Corporation · 2014
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 deviceK134031 Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire…Boston Scientific Corporation · 2014
Class I recalls in this family
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) | K134031 | Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire… | Boston Scientific Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 2 |
| 2005 | 5 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Summary page 1…Catheter Product Code LOX Classification Class 11,21 CER Padt 870.5100 Predicate Emerge TM PTCA Dilatation K130391 July 10, 2013 Devices Catheter (1.20 mm) CrossBoss TM Catheter K1027… | 2013 |
| * | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Summary page 1…ge TM PTCA Dilatation K130391 July 10, 2013 Devices Catheter (1.20 mm) CrossBoss TM Catheter K102725 May 10, 2011 Coyote TM PTA Balloon Dilatation Kill1295 May 31, 2011… | 2011 |
| * | K111295 | .014 Monorail and Otw Pta Balloon Dilatation CathetersSummary page 2…m), K130391 (cleared July 10, 2013); CrossBoss'TM Catheter. K1 02725 (cleared May 10, 2011); Coyote TM PTA Dilatation Catheter, K1 11295 (cleared May 31, 2011); and Asahi Corsair Microcatheter, K083127 (cleared February 3, 2009). Performance… | 2011 |
| * | K083127 | Asahi Corsair MicrocatheterSummary page 1…Coyote TM PTA Balloon Dilatation Kill1295 May 31, 2011 Catheter Asahi Corsair Microcatheter K083127 February 3, 2009 Device The Boston Scientific Threader TM Micro-Dilatation Catheter is a sterile, Descripti… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 16 of the 76 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K130391.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis ( ! 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134031: Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134031
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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