510(k) · Cleared

Cleared

The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02

K062868510(k) TraditionalCleared Jan 19, 2007116-day reviewClass II21 CFR 870.1250

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

Flowcardia, Inc. · DQY Catheter, Percutaneous

Cleared on Jan 19, 2007 as substantially equivalent to K032031 (Intra Luminal Therapeutics, Inc., 2004) after a 116-day review. Its family tree reaches back 6 generations to 1989. 31 later devices descend from it.

Decided: Jan 19, 2007
Review: 116 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K890505 (1989). 10 ancestors in all, the oldest K881787 (1988). 31 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
3 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
2 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
1 generation backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
This deviceK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
Descendant · cites it directly · 28 of its ownK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
Descendant · 2 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
Descendant · 3 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
Descendant · 4 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
Descendant · 4 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2007high 5 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 31 · See all

K072776The Crosser SystemFlowcardia, Inc. · 2007 · cites it directly28descendants
K111338Wildcat CatheterAvinger, Inc. · 2011 · 2 generations on17descendants
K122380Ocelot SystemAvinger, Inc. · 2012 · 3 generations on14descendants
K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 4 generations on12descendants
K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K890505	Usci Grey/Black Guide Wire	C.R. Bard, Inc.	1989	—
−5	K961271	Usci Commander Series Guide Wires	C.R. Bard, Inc.	1996	—
−4	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat…	Guidant Corp.	1999	—
−3	K011986	Safe-Steer Guide Wire System	Intra Luminal Therapeutics, Inc.	2002	—
−2	K021323	Modification to Safe-Steer Guide Wire System	Intra Luminal Therapeutics, Inc.	2002	—
−1	K032031	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	2004	—
0 (this device)	K062868	The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02	Flowcardia, Inc.	2007	—
+1	K072776	The Crosser System	Flowcardia, Inc.	2007	1
+2	K111338	Wildcat Catheter	Avinger, Inc.	2011	—
+3	K122380	Ocelot System	Avinger, Inc.	2012	—
+4	K123532	Ocelot Pixl Catheter	Avinger, Inc.	2012	—
+4	K140185	Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console	Avinger, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	2	0
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2011	3	0
2012	5	0
2014	2	0
2015	1	0
2016	4	0
2017	1	0
2018	1	0
2020	2	0
2021	3	0
2022	1	0
2023	3	0

FIG. 1 — Lineage of K062868, 1989–2023Source: 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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (1)

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
*	K032031	Safe-Cross Radio Frequency Total Occlusion Crossing System Summary page 1 …atheter, 74 DQY / 21 CFR 870.1250 Predicate Device Safe Cross Radio Frequency Total Occlusion Crossing System manufactured by Intraluminal Therapeutics, Inc. (K032031) Device Description The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Trans…	Intra Luminal Therapeutics, Inc.	2004	—

Also cleared against K032031: 1 other device →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K072776	The Crosser System	Flowcardia, Inc.	2007	28
K080765	Crosser LP System	Flowcardia, Inc.	2008	7
K091254	The Crosser 14 Otw Catheter, Model CRU014	Flowcardia, Inc.	2009	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 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
None of the 10 ancestors has a recall.
Of its descendants, K072776 (Flowcardia, Inc., 2007) has gone furthest, with 28 descendants of its own.
1 other device also cites its predicate K032031.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062868

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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