510(k) · Cleared

Cleared

Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300

K032615510(k) SpecialCleared Sep 16, 200322-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Asahi Intecc Co., Ltd. · DQX Wire, Guide, Catheter

Cleared on Sep 16, 2003 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 1 other predicate after a 22-day review. Its family tree reaches back 5 generations to 1989. 52 later devices descend from it.

Decided: Sep 16, 2003
Review: 22 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K890505 (1989). 8 ancestors in all. 52 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 5 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
4 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
3 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
2 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
1 generation backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
This deviceK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
Descendant · cites it directly · 50 of its ownK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
Descendant · 2 generations on · 49 of its ownK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
Descendant · cites it directly · 48 of its ownK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
Descendant · 2 generations on · 36 of its ownK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
Descendant · 3 generations on · 31 of its ownK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2005high 7 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 52 · See all

K043422Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005 · cites it directly50descendants
K062186Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006 · 2 generations on49descendants
K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008 · cites it directly48descendants
K100578Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010 · 2 generations on36descendants
K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd. · 2013 · 3 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K890505	Usci Grey/Black Guide Wire	C.R. Bard, Inc.	1989	—
−4	K961271	Usci Commander Series Guide Wires	C.R. Bard, Inc.	1996	—
−3	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat…	Guidant Corp.	1999	—
−2	K022762	Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000…	Jomed, Inc.	2002	—
−1	K031277	Jowire Asahi Ptca Catheter Guide Wires, Models…	Jomed, Inc.	2003	—
0 (this device)	K032615	Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300	Asahi Intecc Co., Ltd.	2003	—
+1	K043422	Asahi Ptca Guide Wire, J Shape Series	Asahi Intecc Co., Ltd.	2005	—
+2	K062186	Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J	Asahi Intecc Co., Ltd.	2006	—
+1	K070945	Asahi Ptca Guide Wire	Asahi Intecc Co., Ltd.	2008	—
+2	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2008	1	0
2010	2	0
2011	2	0
2013	2	0
2014	2	0
2015	2	0
2016	3	0
2017	4	0
2018	6	0
2019	2	0
2020	2	0
2021	3	0
2022	7	0
2023	4	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K032615, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K022762	Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…	Jomed, Inc.	2002	—
*	K031277	Jowire Asahi Ptca Catheter Guide Wires, Models…	Jomed, Inc.	2003	—

Also cleared against K022762: 22 other devices →

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K043422	Asahi Ptca Guide Wire, J Shape Series	Asahi Intecc Co., Ltd.	2005	50
K070945	Asahi Ptca Guide Wire	Asahi Intecc Co., Ltd.	2008	48
K101986	Asahi Ultimatebros 3 Ptca Guide Wire	Asahi Intecc Co., Ltd.	2011	30
K163426	ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension	Asahi Intecc Co., Ltd.	2017	11
K051062	VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft)…	Flowcardia, Inc.	2005	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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K043422 (Asahi Intecc Co., Ltd., 2005) has gone furthest, with 50 descendants of its own.
22 other devices also cite its predicate K022762.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)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?

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032615 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032615: Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032615

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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