510(k) Report

510(k) · Cleared

Cleared

Crosser Recanalization System

K112308510(k) TraditionalCleared Aug 17, 20116-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

C.R. Bard, Inc. · PDU Catheter For Crossing Total Occlusions

Cleared on Aug 17, 2011 as substantially equivalent to K072776 (Flowcardia, Inc., 2007) and 4 other predicates after a 6-day review. Its family tree reaches back 17 generations to 1987. 2 later devices descend from it.

Decided
Aug 17, 2011
Review
6 days
Class
Class II
Product code
PDU
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K871011 (1987). 63 ancestors in all, the oldest K780551 (1978). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 3 other ancestors2007: 6 other ancestors2008: 2 other ancestors2006: 2 other ancestors2005: 2 other ancestors2004: 2 other ancestors1999: 2 other ancestors1997: 3 other ancestors1996: 3 other ancestors1993: 1 other ancestor1990: 2 other ancestors1989: 2 other ancestors2002: 2 other ancestors1988: 5 other ancestors2000: 2 other ancestors1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1978: 1 other ancestor2016: 1 descendant cleared2021: 1 descendant clearedK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005×2: 2 generations cleared close together, K053460 (2006), K061063 (2006) ×11: 11 generations cleared close together, K081328 (2008), K082186 (2008), K082664 (2008), K083837 (2009), K090325 (2009), K091509 (2009), K092332 (2009), K093456 (2009), K093918 (2010), K100462 (2010), K101221 (2010) K110626 · Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System · Pathway Medical Technologies, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 11 other ancestors4 generations back: 7 other ancestors5 generations back: 4 other ancestors6 generations back: 9 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K110626 · Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System · Pathway Medical Technologies, Inc. · 2011K101221 · Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 · Pathway Medical Technologies, Inc. · 2010K100462 · Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 · Pathway Medical Technologies, Inc. · 2010K093918 · Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2010K093456 · Jetstream G3 System · Pathway Medical Technologies, Inc. · 2009K092332 · Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K091509 · Jetstream G2 NXT System, Model PV20300 · Pathway Medical Technologies, Inc. · 2009K090325 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K083837 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K082664 · Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 · Pathway Medical Technologies, Inc. · 2008K082186 · Modification to Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K081328 · Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K061063 · Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300 · Foxhollow Technologies, Inc. · 2006K053460 · Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, · Fox Hollow Technologies · 2006K043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987−15−10−50
  1. Root · 17 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 13 generations between
  3. 3 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  4. 2 generations backK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  5. 1 generation backK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
  6. This deviceK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
  7. Descendant · cites it directly · 1 of its ownK161208 CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016
  8. Descendant · 2 generations on · 0 of its ownK203363 Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021 · Recalled
Show all 17 generations
  1. Root · 17 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 16 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 15 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 14 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 13 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
  6. 12 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  7. 11 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  8. 10 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
  9. 9 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  10. 8 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  11. 7 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
  12. 6 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
  13. 5 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
  14. 4 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  15. 3 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  16. 2 generations backK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  17. 1 generation backK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
  18. This deviceK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016 · cites it directly1descendant
  • K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−16K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−15K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−14K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−13K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models…Foxhollow Technologies, Inc.2006—
−12K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−11K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−10K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.2008—
−9K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−8K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−7K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.2009—
−6K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).…Pathway Medical Technologies, Inc.2009—
−5K093456Jetstream G3 SystemPathway Medical Technologies, Inc.2009—
−4K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control…Pathway Medical Technologies, Inc.2010—
−3K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.2010—
−2K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.2010—
−1K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System…Pathway Medical Technologies, Inc.2011—
0 (this device)K112308Crosser Recanalization SystemC.R. Bard, Inc.2011—
+1K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.2016—
+2K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198850
198920
199020
199110
199310
199510
199630
199730
199820
199920
200020
200220
200420
200520
200620
200760
200820
200930
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202110
FIG. 1 — Lineage of K112308, 1987–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K072776The Crosser System
Summary page 1
…0.4875, Product Code MCW) Classification: Class Il Classification Panel: Cardiovascular Predicate Devices: ¢« CROSSER™ System o Models: GEN200, CRU14S, CRU14P, CRU18 (K072776; cleared December 7, 2007) o Models: GEN200, CRUO14S, CRUO14P (K091119; cleared May 15, 2009) ' o Models: GEN200, CRUS6 (K092175;…
Flowcardia, Inc.20071
*K091119Modification to the Crosser System
Summary page 1
…l: Cardiovascular Predicate Devices: ¢« CROSSER™ System o Models: GEN200, CRU14S, CRU14P, CRU18 (K072776; cleared December 7, 2007) o Models: GEN200, CRUO14S, CRUO14P (K091119; cleared May 15, 2009) ' o Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) + Diamondback 360 Orbital Atherectomy Syste…
Flowcardia, Inc.2009—
*K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200
Summary page 1
…o Models: GEN200, CRU14S, CRU14P, CRU18 (K072776; cleared December 7, 2007) o Models: GEN200, CRUO14S, CRUO14P (K091119; cleared May 15, 2009) ' o Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) + Diamondback 360 Orbital Atherectomy System (K090521; cleared March 20, 2009) ‘e Jetstream System (K…
Flowcardia, Inc.2010—
*K090521Diamondback 360 DBX
Summary page 1
…ls: GEN200, CRUO14S, CRUO14P (K091119; cleared May 15, 2009) ' o Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) + Diamondback 360 Orbital Atherectomy System (K090521; cleared March 20, 2009) ‘e Jetstream System (K110626; cleared April 20, 2011) FlowCardia, Inc. : [BM[R[D K11220…
Cardiovascular Systems, Inc.20092
*K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…
Summary page 1
…2009) ' o Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) + Diamondback 360 Orbital Atherectomy System (K090521; cleared March 20, 2009) ‘e Jetstream System (K110626; cleared April 20, 2011) FlowCardia, Inc. : [BM[R[D K112208 page 2 of [ Device Description: The CROSSER™ Recan…
Pathway Medical Technologies, Inc.2011—

Also cleared against K072776: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161

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 24 years and passes through 5 companies; a new generation was cleared every 3 months on median.
  • 9 of the 63 ancestors have a recall of any class.
  • Of its descendants, K161208 (Bard Peripheral Vacular, Inc., 2016) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K072776.

How does its category compare?

All PDU devices

PDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · PDU

3in 2025

2007: 42008: 22009: 22010: 32011: 32012: 62013: 12014: 32015: 22016: 22017: 12019: 12020: 22021: 32022: 42023: 32024: 12025: 32026 (partial year): 1
2007high 6 (2012) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PDU

59in 2025

2007: 66 days median2010: 49 days median2011: 91 days median2012: 68 days median2014: 97 days median2021: 144 days median2022: 139 days median2023: 221 days median2025: 59 days median
2007high 221 (2023) · low 49 (2010)2026

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

Recalls per year · PDU

1in 2023

2020: 22023: 1
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PDU

179in 2025

2013: 32014: 102015: 122016: 262017: 2112018: 972019: 832020: 1292021: 1892022: 1562023: 712024: 922025: 179
2007high 211 (2017) · low 0 (2007)2025

MAUDE reports naming product code PDU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200746600
20082—00
20092—00
201034900
201139100
201266800
20131—03
2014397010
20152—012
20162—026
20171—0211
20180—097
20191—083
20202—2129
202131440189
202241390156
20233221171
20241—092
20253590179
20261—0—

What is it indicated for?

The CROSSER™ Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The device is contraindicated for use in carotid arteries.

The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator 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.

Also cleared against K072776

4 other devices cite the same predicate.

  • K111338Wildcat CatheterAvinger, Inc. · 2011
  • K101599RVT Cto DeviceRevascular Therapeutics, Inc. · 2011
  • K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc. · 2010
  • K091119Modification to the Crosser SystemFlowcardia, Inc. · 2009

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in PDU

The PDU category page

  • K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
  • K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc. · 2025
  • K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2025
  • K251376LimFlow ARCLimFlow, Inc. · 2025
  • K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2024

https://510kreport.com/device/K112308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112308: Crosser 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/K112308

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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