510(k) Report

510(k) · Cleared

Cleared

Transit/Rapidtransit/Speedster/Prowler Infusion Catheter

K972518510(k) TraditionalCleared Nov 4, 1997120-day reviewClass II21 CFR 870.1210

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

Cordis Neurovascular, Inc. · KRA Catheter, Continuous Flush

Cleared on Nov 4, 1997 as substantially equivalent to K965181 (Cordis Neurovascular, Inc., 1997) and 2 other predicates after a 120-day review. Its family tree reaches back 1 generation to 1995. 81 later devices descend from it.

Decided
Nov 4, 1997
Review
120 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K945904 (1995). 3 ancestors in all. 81 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor2008: 3 descendants cleared1998: 1 descendant cleared2002: 2 descendants cleared2007: 4 descendants cleared2004: 1 descendant cleared2012: 6 descendants cleared2021: 6 descendants cleared2015: 5 descendants cleared2022: 4 descendants cleared2005: 2 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2017: 6 descendants cleared2014: 3 descendants cleared2018: 6 descendants cleared2016: 5 descendants cleared2023: 4 descendants cleared2006: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2020: 8 descendants cleared2026: 3 descendants cleared2024: 2 descendants cleared2025: 3 descendants clearedK945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 11 descendants3 generations forward: 15 descendants4 generations forward: 22 descendants5 generations forward: 12 descendants6 generations forward: 10 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 19950+5
  1. Root · 1 generation backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
  2. This deviceK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
  3. Descendant · cites it directly · 35 of its ownK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
  4. Descendant · cites it directly · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
  5. Descendant · 2 generations on · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
  6. Descendant · 3 generations on · 20 of its ownK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
  7. Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1998: 12002: 22004: 12005: 22006: 12007: 42008: 32009: 12011: 22012: 62013: 12014: 32015: 52016: 52017: 62018: 62019: 22020: 82021: 62022: 42023: 42024: 22025: 32026: 3
1998high 8 (2020) · low 0 (1999)2026

Most influential descendants

Showing 5 of 81 · See all
  • K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002 · cites it directly35descendants
  • K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · cites it directly34descendants
  • K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · 2 generations on33descendants
  • K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015 · 3 generations on20descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945904Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions1995—
0 (this device)K972518Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc.1997—
+1K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.2002—
+1K062885Stride MicrocatheterAsahi Intecc Co., Ltd.2007—
+2K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.2009—
+3K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.2015—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200220
200410
200520
200610
200740
200830
200910
201120
201260
201310
201430
201550
201650
201760
201860
201920
202080
202160
202240
202340
202420
202530
202630
FIG. 1 — Lineage of K972518, 1995–2026Source: 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 KRA? 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 KRA device

  1. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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? (3)

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
*K965181Ces Infusion Catheter
Summary page 1
…Infusion Catheter e Speedster™ Infusion Catheter e Prowler™ Infusion Catheter Predicate The predicates are listed in the table below: CES Infusion Cordis Endovascular K965181, 3/21/97 KRA Design, materials, Catheters Systems, Inc. sterilization and packaging Venture™ I1 Scimed Life Systems K945904, 5/…
Cordis Neurovascular, Inc.1997—
*K945904Scimed (R) Venture (TM) II Infusion Catheter
Summary page 1
…le below: CES Infusion Cordis Endovascular K965181, 3/21/97 KRA Design, materials, Catheters Systems, Inc. sterilization and packaging Venture™ I1 Scimed Life Systems K945904, 5/19/95 KRA Indications/claims Infusion Catheter UltraFuse-X™ Scimed Life Systems K952872, 7/27/95 KRA Indications/claims Inf…
Scimed Peripheral Interventions1995—
*K952872Sscimed Coronary Guide Wire/Infusion Catheter
Summary page 1
…s Systems, Inc. sterilization and packaging Venture™ I1 Scimed Life Systems K945904, 5/19/95 KRA Indications/claims Infusion Catheter UltraFuse-X™ Scimed Life Systems K952872, 7/27/95 KRA Indications/claims Infusion/Guide Wire Exchange Catheter Classification Class II Performance Performance standar…
Scimed Life Systems, Inc.1995—

Also cleared against K965181: 4 other devices →

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.200235
K062885Stride MicrocatheterAsahi Intecc Co., Ltd.200734
K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.200216
K082519Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp.20089
K974222Ces Masstransit Infusion CatheterCordis Neurovascular, Inc.19980

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K020680 (Cordis Neurovascular, Inc., 2002) has gone furthest, with 35 descendants of its own.
  • 4 other devices also cite its predicate K965181.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 29 (2012)2026

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

Recalls per year · KRA

41so far in 2026, the most since 2007

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
2007high 41 (2026) · low 0 (2017)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KRA

980in 2025

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, 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
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

What is it indicated for?

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.

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 K965181

4 other devices cite the same predicate.

  • K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 20022 recalls
  • K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002
  • K974222Ces Masstransit Infusion CatheterCordis Neurovascular, Inc. · 1998
  • K971306FG Infusion CatheterCordis Neurovascular, Inc. · 1997

More from Cordis Neurovascular, Inc.

37 FDA decisions under this applicant name. See the company

  • K082324Trufill DCS SyringeCordis Neurovascular, Inc. · 2008
  • K080967Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the…Cordis Neurovascular, Inc. · 2008
  • K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007
  • K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2007
  • K063254The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemCordis Neurovascular, Inc. · 2006

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K972518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972518: Transit/Rapidtransit/Speedster/Prowler Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972518

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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