510(k) Report

510(k) · Cleared

Cleared

Micrus Courier Enzo Microcatheter 0.0190

K072526510(k) SpecialCleared Oct 5, 200728-day reviewClass II21 CFR 870.1200

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

Micrus Endovascular Corporation · DQO Catheter, Intravascular, Diagnostic

Cleared on Oct 5, 2007 as substantially equivalent to K070456 (Micrus Endovascular Corporation, 2007) after a 28-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it.

Decided
Oct 5, 2007
Review
28 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K960806 (1996). 9 ancestors in all, the oldest K925813 (1994). 5 later devices descend from it, 1 citing it directly.

  1. Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 5 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 4 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. 3 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
  5. 2 generations backK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
  6. 1 generation backK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
  7. This deviceK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
  8. Descendant · cites it directly · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
  9. Descendant · 2 generations on · 2 of its ownK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
  10. Descendant · 3 generations on · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
  11. Descendant · 2 generations on · 0 of its ownK211110 Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022
  12. Descendant · 2 generations on · 0 of its ownK211525 SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. · 2021

Most influential descendants

Showing 5 of 5 · See all
  • K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · cites it directly4descendants
  • K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019 · 2 generations on2descendants
  • K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020 · 3 generations on1descendant
  • K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022 · 2 generations on0descendants
  • K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K960806Turbo TrackerTarget Therapeutics1996—
−5K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−4K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
−3K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp20047
−2K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation2006—
−1K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation2007—
0 (this device)K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation2007—
+1K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.2016—
+2K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.2019—
+3K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.2020—
+2K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.2022—
+2K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201910
202010
202110
202210
FIG. 1 — Lineage of K072526, 1996–2022Source: 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
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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
*K070456Micrus Courier Enzo Microcatheter 0.017
Summary page 1
…0190" Generic/Common Name: Diagnostic intravascular catheter (21 CFR § 870.1200) PREDICATE DEVICE Micrus® Courier EnzoTM Microcatheter 0.0170" (reference: K070456) INTENDED USE I The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents,…
Micrus Endovascular Corporation2007—

Also cleared against K070456: 1 other device →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.20164

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?

  • The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K161921 (Merit Medical Systems, Inc., 2016) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K070456.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072526: Micrus Courier Enzo Microcatheter 0.0190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072526

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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