510(k) · Cleared
ClearedASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Feb 12, 2018 as substantially equivalent to K133865 (Asahi Intecc Co., Ltd., 2014) and 10 other predicates after a 229-day review. Its family tree reaches back 13 generations to 1989. 7 later devices descend from it.
- Decided
- Feb 12, 2018
- Review
- 229 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 13 generations to K890505 (1989). 40 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations between
- 3 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 2 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 1 generation backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- This deviceK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter…Vascular Solutions, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK220647 GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271)…Vascular Solutions, LLC · 2022
- Descendant · cites it directly · 0 of its ownK212167 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit…Vascular Solutions, LLC · 2022
- Descendant · cites it directly · 0 of its ownK211898 ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK193322 NovaCross CTO MicrocatheterNitiloop, Ltd. · 2020
Show all 13 generations
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 12 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 11 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 10 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 9 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 8 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 7 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 6 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 5 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 4 generations backK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- 3 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 2 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 1 generation backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- This deviceK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC · 2022 · cites it directly1descendant
- K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC · 2022 · 2 generations on0descendants
- K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC · 2022 · cites it directly0descendants
- K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd. · 2021 · cites it directly0descendants
- K193322NovaCross CTO MicrocatheterNitiloop, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −12 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −11 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −10 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −9 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −8 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −7 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −6 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −5 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| −4 | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| −3 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| −2 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| −1 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
| 0 (this device) | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro… | Asahi Intecc Co., Ltd. | 2018 | — |
| +1 | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike… | Vascular Solutions, LLC | 2022 | — |
| +2 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast… | Vascular Solutions, LLC | 2022 | — |
| +1 | K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior… | Vascular Solutions, LLC | 2022 | — |
| +1 | K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 | Asahi Intecc Co., Ltd. | 2021 | — |
| +1 | K193322 | NovaCross CTO Microcatheter | Nitiloop, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 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.
Planning a device in DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133865 | Asahi Gaia First, Second, ThirdSummary page 5…DQY – Catheter, Percutaneous PREDICATE DEVICES: ASAHI® PTCA Guide Wire • ASAHI Gaia First, Gaia Second, Gaia Third (K133865) • ASAHI Fielder XT (K072431) • ASAHI Fielder XT-A, Fielder XT-R… | 2014 |
| * | K072431 | Asahi Ptca Guide Wire, X-TremeSummary page 5…ASAHI® PTCA Guide Wire • ASAHI Gaia First, Gaia Second, Gaia Third (K133865) • ASAHI Fielder XT (K072431) • ASAHI Fielder XT-A, Fielder XT-R (K153106) • ASAHI MIRACLEbros… | 2007 |
| * | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-RSummary page 5…First, Gaia Second, Gaia Third (K133865) • ASAHI Fielder XT (K072431) • ASAHI Fielder XT-A, Fielder XT-R (K153106) • ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K02276… | 2016 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 5…• ASAHI Fielder XT-A, Fielder XT-R (K153106) • ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K022762, K031277) • ASAHI MIRACLEbros 12 (K052339) • ASAHI ULTIMATEbros 3… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 5…I Fielder XT-A, Fielder XT-R (K153106) • ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K022762, K031277) • ASAHI MIRACLEbros 12 (K052339) • ASAHI ULTIMATEbros 3 (K101986… | 2003 |
| * | K052339 | Asahi Ptca Guide WireSummary page 5…• ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K022762, K031277) • ASAHI MIRACLEbros 12 (K052339) • ASAHI ULTIMATEbros 3 (K101986) • ASAHI Confianza (K022762, K03… | 2005 |
| * | K101986 | Asahi Ultimatebros 3 Ptca Guide WireSummary page 5…(K022762, K031277) • ASAHI MIRACLEbros 12 (K052339) • ASAHI ULTIMATEbros 3 (K101986) • ASAHI Confianza (K022762, K031277) • ASAHI Confianza Pro (K041… | 2011 |
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 5…• ASAHI ULTIMATEbros 3 (K101986) • ASAHI Confianza (K022762, K031277) • ASAHI Confianza Pro (K041531) • ASAHI Confianza Pro 12 (K052339) ASAHI Intecc Co., Ltd.… | 2004 |
| * | K083127 | Asahi Corsair MicrocatheterSummary page 6…CA Guide Wires and ASAHI Corsair Microcatheters ASAHI® Corsair® / ASAHI Corsair® Pro Microcatheter • ASAHI Corsair (K083127, K151103) • ASAHI Corsair Pro (K161126) INTENDED USE/INDICATIONS FOR USE ASAHI PTCA Guide Wi… | 2009 |
| * | K151103 | ASAHI Corsair MicrocatheterSummary page 6…Wires and ASAHI Corsair Microcatheters ASAHI® Corsair® / ASAHI Corsair® Pro Microcatheter • ASAHI Corsair (K083127, K151103) • ASAHI Corsair Pro (K161126) INTENDED USE/INDICATIONS FOR USE ASAHI PTCA Guide Wires:… | 2015 |
| * | K161126 | ASAHI Corsair ProSummary page 6…ASAHI® Corsair® / ASAHI Corsair® Pro Microcatheter • ASAHI Corsair (K083127, K151103) • ASAHI Corsair Pro (K161126) INTENDED USE/INDICATIONS FOR USE ASAHI PTCA Guide Wires: ASAHI PTCA Guide Wires are intended to facilitate the… | 2016 |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold… | 2022 | 1 |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | 2022 | 0 |
| K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 | 2021 | 0 |
| K193322 | NovaCross CTO Microcatheter | 2020 | 0 |
| K192599 | ASAHI PTCA Guide Wire ASAHI Gaia Next | 2020 | 0 |
| K182420 | ASAHI Corsair Pro XS | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 40 ancestors has a recall.
- Of its descendants, K212211 (Vascular Solutions, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K133865.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. This product is intended to provide support to facilitate the placement of guide…
Read the full statement (124 words)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171933 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171933: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171933
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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