510(k) Report

510(k) · Cleared

Cleared

Marksmann Catheter

K091559510(k) TraditionalCleared Sep 18, 2009113-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

Chestnut Medical Technologies, Inc. · KRA Catheter, Continuous Flush

Cleared on Sep 18, 2009 after a 113-day review. The FDA summary names no predicate by number. 14 later devices descend from it.

Decided
Sep 18, 2009
Review
113 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
0

14 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2015: 3 descendants cleared2017: 2 descendants cleared2013: 2 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2021: 2 descendants cleared2023: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK091559 Marksmann CatheterChestnut Medical Technologies, Inc. · 2009
  2. Descendant · cites it directly · 6 of its ownK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
  3. Descendant · 2 generations on · 4 of its ownK180959 Phenom 27 CatheterCathera, Inc. · 2018
  4. Descendant · cites it directly · 4 of its ownK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
  5. Descendant · cites it directly · 3 of its ownK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013: 22015: 32017: 22018: 12019: 12021: 22023: 12026: 2
2013high 3 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · 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
  • K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · cites it directly4descendants
  • K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · cites it directly3descendants
  • K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091559Marksmann CatheterChestnut Medical Technologies, Inc.2009—
+1K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.2015—
+2K180959Phenom 27 CatheterCathera, Inc.2018—
+1K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.2013—
+1K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20131
+2K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201530
201720
201810
201910
202120
202310
202620
FIG. 1 — Lineage of K091559, 2009–2026Source: 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 14.5 · 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?

The FDA summary names no predicate by number.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.20156
K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134
K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20133
K170406Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC20170
K143398Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC20150

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, K151638 (Cathera, Inc., 2015) has gone furthest, with 6 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. 2009, this device’s year, is highlighted.

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 MarksmanTM Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

Indications for use as stated in the FDA summary.

More from Chestnut Medical Technologies, Inc.

3 FDA decisions under this applicant name. See the company

  • K093977Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XXChestnut Medical Technologies, Inc. · 2010
  • K043580Alligator Retrieval Device (Ard)Chestnut Medical Technologies, Inc. · 20051 Class I recall

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/K091559 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091559: Marksmann Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091559

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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