510(k) · Cleared
Recalled · Class II · 2023Crosser iQ CTO Recanalization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Aug 12, 2021 as substantially equivalent to K161208 (Bard Peripheral Vacular, Inc., 2016) after a 269-day review. Its family tree reaches back 19 generations to 1987. It has been recalled once.
- Decided
- Aug 12, 2021
- Review
- 269 days
- Class
- Class II
- Product code
- PDU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 19 generations to K871011 (1987). 65 ancestors in all, the oldest K780551 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 15 generations between
- 3 generations backK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
- 2 generations backK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
- 1 generation backK161208 CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016
- This deviceK203363 Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021
Show all 19 generations
- Root · 19 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 18 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 17 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 16 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 15 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- 14 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 13 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 12 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- 11 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 10 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 9 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
- 8 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 7 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
- 6 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 5 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 4 generations backK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
- 3 generations backK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
- 2 generations backK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
- 1 generation backK161208 CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016
- This deviceK203363 Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −18 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −17 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −16 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −15 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| −14 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −13 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −12 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| −11 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −10 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −9 | K091509 | Jetstream G2 NXT System, Model PV20300 | Pathway Medical Technologies, Inc. | 2009 | — |
| −8 | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).… | Pathway Medical Technologies, Inc. | 2009 | — |
| −7 | K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | 2009 | — |
| −6 | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control… | Pathway Medical Technologies, Inc. | 2010 | — |
| −5 | K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −4 | K101221 | Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −3 | K110626 | Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System… | Pathway Medical Technologies, Inc. | 2011 | — |
| −2 | K112308 | Crosser Recanalization System | C.R. Bard, Inc. | 2011 | — |
| −1 | K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016 | — |
| 0 (this device) | K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K161208 | CROSSER CTO Recanalization CatheterSummary page 4…ass II Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1250 Predicate Device: Crosser™ CTO Recanalization Catheter (K161208; cleared May 24, 2016) Reference Devices: Crosser™ CTO Recanalization System (K112308; cleared August 17, 201… | 2016 |
| † | K112308 | Crosser Recanalization System | 2011 |
| † | K090621 | Flowcardia Flowmater Injector, Model Inj 100 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2023 | Class II | Z-0676-2024 | Process design | Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 9 of the 65 ancestors have a recall of any class.
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. 2021, 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 BD Recanalization System (console and footswitch) and Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.
Crosser iQ™ Ultrasonic CTO Device: The Crosser iQ™ Ultrasonic CTO Device is intended for use only with the BD Recanalization System (console and footswitch).
BD Recanalization System: The BD Recanalization System (console and footswitch) is intended for use only with the Crosser iQ™ Ultrasonic CTO Crossing Device.
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/K203363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203363: Crosser iQ CTO Recanalization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203363
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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