510(k) · Cleared
Recalled · 2006Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · KRA Catheter, Continuous Flush
Cleared on May 22, 2002 as substantially equivalent to K965181 (Cordis Neurovascular, Inc., 1997) and 3 other predicates after a 7-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- May 22, 2002
- Review
- 7 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945904 (1995). 7 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 2 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 1 generation backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- This deviceK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK180959 Phenom 27 CatheterCathera, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK113289 Orion Micro CatheterMicro Therapeutics, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 2 generations on · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc. · 2015 · cites it directly6descendants
- K180959Phenom 27 CatheterCathera, Inc. · 2018 · 2 generations on4descendants
- K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012 · cites it directly3descendants
- K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021 · 2 generations on2descendants
- K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −2 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −1 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| 0 (this device) | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | — |
| +1 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015 | — |
| +2 | K180959 | Phenom 27 Catheter | Cathera, Inc. | 2018 | — |
| +1 | K113289 | Orion Micro Catheter | Micro Therapeutics, Inc. | 2012 | — |
| +2 | K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021 | — |
| +2 | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 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 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K965181 | Ces Infusion CatheterSummary page 2…2 === Summary of Safety and Effectiveness, Continued Predicate Devices L02159 | 0-000026 Cordis Neurovascular, The predicate devices are listed in the table below: K965181 PROWLER® Infusion Catheters Inc. K972518 PROWLER® PLUS Cordis Neurovascular, K993266 74KRA Infusion Catheters Inc. PROWLER® I… | 1997 |
| * | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion CatheterSummary page 2…Continued Predicate Devices L02159 | 0-000026 Cordis Neurovascular, The predicate devices are listed in the table below: K965181 PROWLER® Infusion Catheters Inc. K972518 PROWLER® PLUS Cordis Neurovascular, K993266 74KRA Infusion Catheters Inc. PROWLER® Infusion Cordis Neurovascular, K003925 74KRA… | 1997 |
| * | K993266 | Prowler Plus Infusion CatheterSummary page 2…026 Cordis Neurovascular, The predicate devices are listed in the table below: K965181 PROWLER® Infusion Catheters Inc. K972518 PROWLER® PLUS Cordis Neurovascular, K993266 74KRA Infusion Catheters Inc. PROWLER® Infusion Cordis Neurovascular, K003925 74KRA Catheters with pre-shaped Inc. tips PROWLE… | 1999 |
| * | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsSummary page 2…93266 74KRA Infusion Catheters Inc. PROWLER® Infusion Cordis Neurovascular, K003925 74KRA Catheters with pre-shaped Inc. tips PROWLER® SELECT™ Cordis Neurovascular, | K020680 /3/27/02 74KRA 10 and 14 Infusion Inc. Catheters with and without pre-shaped tips Summary of Studies Summary of Substantial Eq… | 2002 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | 2015 | 6 |
| K113289 | Orion Micro Catheter | 2012 | 3 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | 2022 | 1 |
| K043538 | Hypertransit Infusion Catheter | 2005 | 1 |
| K210838 | Prowler Select Plus; Prowler EX | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2006 | Not classified | Z-1483-06 | Other | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a… |
| Aug 11, 2006 | Not classified | Z-1482-06 | Other | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K151638 (Cathera, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K965181.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The PROWLER® SELECT™ (10, 14 and 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.
https://510kreport.com/device/K021591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021591
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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