510(k) · Cleared

Cleared

Vision Wire Coronary Guidewire

K082935510(k) TraditionalCleared Dec 4, 200864-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

Biotronik, Inc. · DQX Wire, Guide, Catheter

Cleared on Dec 4, 2008 as substantially equivalent to K030019 (Guidant Corp., 2003) and 2 other predicates after a 64-day review. Its family tree reaches back 5 generations to 2000.

Decided: Dec 4, 2008
Review: 64 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K002206 (2000). 6 ancestors in all, the oldest K964272 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
4 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
3 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
2 generations backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
1 generation backK061453 HI-Torque Whisper View Guide WireGuidant Corp. · 2006
This deviceK082935 Vision Wire Coronary GuidewireBiotronik, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
−4	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
−3	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat…	Guidant Corp.	2002	—
−2	K030019	Modification to HI-Torque Whisper Guidewire	Guidant Corp.	2003	—
−1	K061453	HI-Torque Whisper View Guide Wire	Guidant Corp.	2006	—
0 (this device)	K082935	Vision Wire Coronary Guidewire	Biotronik, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K082935, 2000–2008Source: 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? (3)

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
*	K030019	Modification to HI-Torque Whisper Guidewire Summary page 1 …devices for the VisionWire coronary guidewire: · Guidant's HI-TORQUE WHISPER - Guidewires (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588), #K030019, cleared on 01-24-2003 and HI-TORQUE WHISPER VIEW Guidewire (Model #4631-4639), #K061453, cleared on 06-22-2006 * M…	Guidant Corp.	2003	—
*	K061453	HI-Torque Whisper View Guide Wire Summary page 1 …dels 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588), #K030019, cleared on 01-24-2003 and HI-TORQUE WHISPER VIEW Guidewire (Model #4631-4639), #K061453, cleared on 06-22-2006 * Medtronic Performr Electrode Catheter, #K964272, cleared on 01-23-1997 Indications for Use: The Vi…	Guidant Corp.	2006	—
*	K964272	Performr Series EP Diagnostic Catheters Summary page 1 …9, cleared on 01-24-2003 and HI-TORQUE WHISPER VIEW Guidewire (Model #4631-4639), #K061453, cleared on 06-22-2006 * Medtronic Performr Electrode Catheter, #K964272, cleared on 01-23-1997 Indications for Use: The VisionWire coronary guidewire is intended for the following applications: · I…	Medtronic Cardiorhythm	1997	—

Also cleared against K030019: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
None of the 6 ancestors has a recall.
3 other devices also cite its predicate K030019.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

The VisionWire coronary guide wire is intended for the following applications:

· Its positioning in the coronary vascular system (probing coronary vessel anatomy)

· Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:

o Measuring the left ventricular threshold

o Measuring the intracardiac signals

o Temporary pacing of the left ventricle

· As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082935 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082935: Vision Wire Coronary Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082935

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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