510(k) Report

510(k) · Cleared

Cleared

Prowler Plus Infusion Catheter

K993266510(k) SpecialCleared Oct 28, 199928-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 Oct 28, 1999 after a 28-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.

Decided
Oct 28, 1999
Review
28 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
0

36 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2015: 2 descendants cleared2004: 1 descendant cleared2012: 3 descendants cleared2021: 3 descendants cleared2022: 1 descendant cleared2005: 2 descendants cleared2018: 2 descendants cleared2007: 3 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2019: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK993266 Prowler Plus Infusion CatheterCordis Neurovascular, Inc. · 1999
  2. Descendant · cites it directly · 35 of its ownK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
  3. Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  4. Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  5. Descendant · cites it directly · 16 of its ownK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
  6. Descendant · 4 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12005: 22006: 12007: 32008: 22012: 32014: 12015: 22016: 12017: 22018: 22019: 12020: 22021: 32022: 12023: 32025: 12026: 3
2002high 3 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 36 · See all
  • K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002 · cites it directly35descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants
  • K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002 · cites it directly16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993266Prowler Plus Infusion CatheterCordis Neurovascular, Inc.1999—
+1K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.2002—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+1K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without…Cordis Neurovascular, Inc.20022
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200520
200610
200730
200820
201230
201410
201520
201610
201720
201820
201910
202020
202130
202210
202330
202510
202630
FIG. 1 — Lineage of K993266, 1999–2026Source: 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? (2)

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
*—Cordis Endovascular Systems, Inc. Prowler Infusion Catheter
Named without a submission number
—
*—Rapid Transit Infusion Catheter
Named without a submission number
—

What descends from it? (36)

See all 36

3 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
K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.200216
K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.20156

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?

  • Of its descendants, K020680 (Cordis Neurovascular, Inc., 2002) has gone furthest, with 35 descendants of its own.

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?

The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K993266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993266: Prowler Plus 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/K993266

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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