510(k) · Cleared

Cleared

B. Braun Guidewires

K961107510(k) TraditionalCleared Oct 1, 1996195-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

B.Braun Medical, Inc. · DQX Wire, Guide, Catheter

Cleared on Oct 1, 1996 as substantially equivalent to K852123 (Advanced Cardiovascular Systems, Inc., 1985) and 27 other predicates after a 195-day review. Its family tree reaches back 1 generation to 1985.

Decided: Oct 1, 1996
Review: 195 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 28

Its longest line of descent runs back 1 generation to K852123 (1985). 28 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK852123 Wholey HI-Torque Guide WiresAdvanced Cardiovascular Systems, Inc. · 1985
This deviceK961107 B. Braun GuidewiresB.Braun Medical, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K852123	Wholey HI-Torque Guide Wires	Advanced Cardiovascular Systems, Inc.	1985	—
0 (this device)	K961107	B. Braun Guidewires	B.Braun Medical, Inc.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1986	5	0
1987	1	0
1988	6	0
1989	1	0
1990	1	0
1991	3	0
1992	4	0
1993	3	0
1994	1	0
1995	1	0

FIG. 1 — Lineage of K961107, 1985–1996Source: 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

Get a 510(k) Report

What was it cleared against? (28)

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
*	K852123	Wholey HI-Torque Guide Wires Summary page 1 …ager Date Prepared: June 21, 1996 Common or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755,…	Advanced Cardiovascular Systems, Inc.	1985	—
*	K852354	Wholey HI-Torque Guide Wires Summary page 1 …Prepared: June 21, 1996 Common or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502,…	Advanced Cardiovascular Systems, Inc.	1985	—
*	K854830	Acs HI-Torque Tapered Diameter Guide Wires Summary page 1 …June 21, 1996 Common or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K…	Advanced Cardiovascular Systems, Inc.	1986	—
*	K861574	Acs HI-Torque Tapered Diameter Guide Wire Summary page 1 …1996 Common or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K…	Advanced Cardiovascular Systems, Inc.	1986	—
*	K861765	Acs Wholey HI-Torque Guide Wire Summary page 1 …mon or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K…	Advanced Cardiovascular Systems, Inc.	1986	—
*	K862360	Acs HI-Torque Flex-T Guide Wire Summary page 1 …ual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K…	Advanced Cardiovascular Systems, Inc.	1986	—
*	K864585	Acs HI-Torque Floppy Guide Wire, 0.018 Inch	Advanced Cardiovascular Systems, Inc.	1986	—
*	K872220	Acs HI-Torque Flex-T Guide Wire (Modification) Summary page 1 …Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / o…	Advanced Cardiovascular Systems, Inc.	1987	—
*	K874202	Acs HI-Torque Guide Wires Summary page 1 …s Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156…	Advanced Cardiovascular Systems, Inc.	1988	—
*	K874776	Acs 0.025-in HI-Torq Modif J/Stand Telesc Guidewir Summary page 1 …Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target G…	Advanced Cardiovascular Systems, Inc.	1988	—
*	K881787	Acs HI-Torque Standard & Intermedi. Guide Wire Summary page 1 …cation Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires…	Advanced Cardiovascular Systems, Inc.	1988	—
*	K881897	Acs HI-Torque Floppy/Floppy II/Inter./Standard GW Summary page 1 …me: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198…	Advanced Cardiovascular Systems, Inc.	1988	—
*	K884262	Acs (R) HI-Torque Gold (TM) Guide Wire Summary page 1 …Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912…	Advanced Cardiovascular Systems, Inc.	1988	—
*	K884895	Acs 0.010 HI-Torque Floppy Gold Guide Wire Summary page 1 …atheter Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K91…	Advanced Cardiovascular Systems, Inc.	1989	—
*	K902755	.018 HI-Torque Floppy Guide Wire W/ Preshaped Tip Summary page 1 …Substantial Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI…	Advanced Cardiovascular Systems, Inc.	1990	—
*	K905502	.010 HI-Torque Floppy Guide Wire W/Preshaped Tip Summary page 1 …al Equivalence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewir…	Advanced Cardiovascular Systems, Inc.	1991	—
*	K913328	.010 HI-Torque Plus (TM) Guide Wire Summary page 1 …lence: ACS Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K9240…	Advanced Cardiovascular Systems, Inc.	1991	—
*	K913631	.014 HI-Torque Floppy Pathfinder Guide Wire Summary page 1 …S Guidewires-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K…	Advanced Cardiovascular Systems, Inc.	1991	—
*	K915723	.10' HI-Torque Floppy, Inter. & Stand. Guide Wire Summary page 1 …res-- K852123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 G…	Advanced Cardiovascular Systems, Inc.	1992	—
*	K925381	Acs HI-Torque Balance (TM) Guide Wire Summary page 1 …2123, K852354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire…	Advanced Cardiovascular Systems, Inc.	1993	—
*	K934602	Acs.018 HI-Torque Floppy Guide Wire - Acs HI-Torque Floppy Extra Support Guide Wire Summary page 1 …2354 , K854830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device De…	Advanced Cardiovascular Systems, Inc.	1993	—
*	K942066	Acs HI-Torque Extra S'port Guide Wire Summary page 1 …54830, K861574, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description…	Advanced Cardiovascular Systems, Inc.	1994	—
*	K950156	Acs HI-Torque Extra S'port (TM) Guide Wire Summary page 1 …4, K861765, K862360, K86458S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun G…	Advanced Cardiovascular Systems, Inc.	1995	—
*	K884198	Target Therapeutics Seeker-16 Steerable Guidewire Summary page 1 …S5, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, sh…	Target Therapeutics	1988	—
*	K922912	Seeker Lite - 10 Summary page 1 …20, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, shapeable g…	Target Therapeutics	1992	—
*	K914032	Nitinol Seeker (R) Guide Wires Summary page 1 …K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, shapeable guidewire. The…	Target Therapeutics	1992	—
*	K924009	Intravascular Guide Wire and Extension Wire Summary page 1 …, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available i…	Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard	1992	—
*	K933466	Usci Mach 10 Guide Wire with Pro/Pel Coating Summary page 1 …84895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety o…	C.R. Bard, Inc.	1993	—

Also cleared against K852123: 1 other device →

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?

None of the 28 ancestors has a recall.
1 other device also cites its predicate K852123.

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?

The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral,reproductive,or nuerological procedures.

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/K961107 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961107: B. Braun Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961107

Report an extraction error

Are you the manufacturer?

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