510(k) · Cleared
ClearedModification to the 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 May 15, 2009 as substantially equivalent to K072776 (Flowcardia, Inc., 2007) after a 28-day review. Its family tree reaches back 8 generations to 1989. 5 later devices descend from it.
- Decided
- May 15, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K890505 (1989). 12 ancestors in all, the oldest K881787 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 4 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 2 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 1 generation backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- This deviceK091119 Modification to the Crosser SystemFlowcardia, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK161208 CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK101599 RVT Cto DeviceRevascular Therapeutics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK203363 Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK140288 Truepath Cto DeviceBoston Scientific Corp · 2014
Most influential descendants
Showing 5 of 5 · See all- K112308Crosser Recanalization SystemC.R. Bard, Inc. · 2011 · cites it directly2descendants
- K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016 · 2 generations on1descendant
- K101599RVT Cto DeviceRevascular Therapeutics, Inc. · 2011 · cites it directly1descendant
- K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021 · 3 generations on0descendants
- K140288Truepath Cto DeviceBoston Scientific Corp · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −4 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −2 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −1 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| 0 (this device) | K091119 | Modification to the Crosser System | Flowcardia, Inc. | 2009 | — |
| +1 | K112308 | Crosser Recanalization System | C.R. Bard, Inc. | 2011 | — |
| +2 | K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016 | — |
| +1 | K101599 | RVT Cto Device | Revascular Therapeutics, Inc. | 2011 | — |
| +3 | K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021 | 1 |
| +2 | K140288 | Truepath Cto Device | Boston Scientific Corp | 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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K072776 | The Crosser SystemSummary page 1…x: (408) 617-9198 DQY ‘I'he CROSSER System Percutaneous Catheter Percutaneous Catheter, 74 DQY /21 CFR 870.1250 The CROSSER System manufactured by FlowCardia, Inc. (K072776) Device Description The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, high- frequency Transducer,… | 2007 |
What descends from it? (5)
2 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)
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 20 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K112308 (C.R. Bard, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K072776.
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. 2009, 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/K091119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091119: Modification to the Crosser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091119
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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