510(k) · Cleared
Recalled · 2009The Crosser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flowcardia, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Dec 7, 2007 as substantially equivalent to K062868 (Flowcardia, Inc., 2007) after a 70-day review. Its family tree reaches back 7 generations to 1989. 28 later devices descend from it. It has been recalled once.
- Decided
- Dec 7, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- PDU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890505 (1989). 11 ancestors in all, the oldest K881787 (1988). 28 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 2 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 1 generation backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- This deviceK072776 The Crosser SystemFlowcardia, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 2 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- Descendant · 4 generations on · 6 of its ownK152275 Pantheris SystemAvinger, Inc. · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K111338Wildcat CatheterAvinger, Inc. · 2011 · cites it directly17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 2 generations on14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 3 generations on12descendants
- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 3 generations on7descendants
- K152275Pantheris SystemAvinger, Inc. · 2015 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −2 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −1 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| 0 (this device) | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | — |
| +1 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +2 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +3 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| +3 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| +4 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
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 |
|---|---|---|
| 2009 | 1 | 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 |
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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Summary page 1…Name: Percutaneous Catheter Classification Name: Percutancous Catheter, 74 DQY /21 CFR 870.1250 Predicate Device The CROSSER System manufactured by FlowCardia, Inc. (K062868) Indications for Use: The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyo… | 2007 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2009 | Not classified | Z-0938-2011 | Employee error | Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life. |
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 2.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K111338 (Avinger, Inc., 2011) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K062868.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
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/K072776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072776: The Crosser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072776
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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