510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Modified Concentirc Microcatheter

K113260510(k) SpecialCleared Mar 9, 2012126-day reviewClass II21 CFR 870.1200Recalls 5

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

Concentric Medical, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Mar 9, 2012 as substantially equivalent to K111619 (Concentric Medical, Inc., 2011) after a 126-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it. It has been recalled 5 times.

Decided
Mar 9, 2012
Review
126 days
Class
Class II
Product code
DQO
Recalls
5
Predicates
1

Its longest line of descent runs back 3 generations to K003086 (2001). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK003086 · Concentric Micro Catheter, Models 90001 to 90008 · Concentric Medical, Inc. · 2001K091961 · Modified Concentric Microcatheter, Model 90047 · Concentric Medical, Inc. · 2009K111619 · Modified Concentric Microcatheter · Concentric Medical, Inc. · 2011200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K111619 · Modified Concentric Microcatheter · Concentric Medical, Inc. · 2011K091961 · Modified Concentric Microcatheter, Model 90047 · Concentric Medical, Inc. · 2009K003086 · Concentric Micro Catheter, Models 90001 to 90008 · Concentric Medical, Inc. · 20010
  1. Root · 3 generations backK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
  2. 2 generations backK091961 Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc. · 2009
  3. 1 generation backK111619 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2011
  4. This deviceK113260 Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012
  5. Descendant · cites it directly · 4 of its ownK192122 Trevo Trak 21 MicrocatheterStryker · 2019 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK211594 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · Recalled
  7. Descendant · 3 generations on · 0 of its ownK261889 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026
  8. Descendant · 3 generations on · 0 of its ownK250960 DUO MicrocatheterRev Neuro, LLC · 2025
  9. Descendant · 2 generations on · 0 of its ownK202926 Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12019: 12021: 12022: 12025: 12026: 1
2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K192122Trevo Trak 21 MicrocatheterStryker · 2019 · cites it directly4descendants
  • K211594Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · 2 generations on2descendants
  • K261889Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026 · 3 generations on0descendants
  • K250960DUO MicrocatheterRev Neuro, LLC · 2025 · 3 generations on0descendants
  • K202926Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003086Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc.2001—
−2K091961Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc.2009—
−1K111619Modified Concentric MicrocatheterConcentric Medical, Inc.2011—
0 (this device)K113260Modified Concentirc MicrocatheterConcentric Medical, Inc.2012—
+1K192122Trevo Trak 21 MicrocatheterStryker20191
+2K211594Trevo Trak 21 MicrocatheterStryker Neurovascular20213
+3K261889Trevo Trak 21 MicrocatheterStryker Neurovascular2026—
+3K250960DUO MicrocatheterRev Neuro, LLC2025—
+2K202926Micro CatheterShanghai Heartcare Medical Technology Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201910
202110
202210
202510
202610
FIG. 1 — Lineage of K113260, 2001–2026Source: 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 DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (1)

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
*K111619Modified Concentric Microcatheter
Summary page 1
…x 650-237-5230 Facility Registration #2954917 Contact: Kirsten Valley Predicate Device: Concentric Microcatheter (K1 11619) Device Description The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for u…
Concentric Medical, Inc.2011—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K192122Trevo Trak 21 MicrocatheterStryker20194
K131437Modified Concentric MicrocatheterConcentric Medical, Inc.20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 23, 2024Class IIZ-1904-2024Process designNeurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin…
Nov 28, 2017Class IIZ-0347-2018Packaging process controlStryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Nov 3, 2017Class IIZ-0275-2018Labeling Change ControlStryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Nov 3, 2017Class IIZ-0276-2018Labeling Change ControlStryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Nov 3, 2017Class IIZ-0277-2018Labeling Change ControlStryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K192122 (Stryker, 2019) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Indications for use as stated in the FDA summary.

More from Concentric Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. · 20181 recall
  • DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo…Concentric Medical, Inc. · 2016
  • K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc. · 2015
  • K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 20153 recalls
  • K133177Modified HD Guide CatheterConcentric Medical, Inc. · 20143 recalls

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K113260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113260: Modified Concentirc Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113260

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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