510(k) Report

510(k) · Cleared

Cleared

Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00

K061963510(k) SpecialCleared Aug 4, 200623-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 Aug 4, 2006 as substantially equivalent to K060116 (Micrus Endovascular Corporation, 2006) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1996. 7 later devices descend from it.

Decided
Aug 4, 2006
Review
23 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K960806 (1996). 7 ancestors in all, the oldest K925813 (1994). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor1994: 1 other ancestor2007: 2 descendants cleared2016: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant clearedK960806 · Turbo Tracker · Target Therapeutics · 1996K994155 · Excelsior 1018 Microcatheter · Boston Scientific, Target · 2000K013789 · Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 · Boston Scientific, Target · 2001 · recalledK042568 · Excelsior 1018 and SL-10 Microcatheters · Boston Scientific Corp · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K042568 · Excelsior 1018 and SL-10 Microcatheters · Boston Scientific Corp · 2004 · recalledK013789 · Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 · Boston Scientific, Target · 2001 · recalledK994155 · Excelsior 1018 Microcatheter · Boston Scientific, Target · 2000K960806 · Turbo Tracker · Target Therapeutics · 19960
  1. Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 3 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 2 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. 1 generation backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
  5. This deviceK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
  6. Descendant · cites it directly · 6 of its ownK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
  7. Descendant · 2 generations on · 5 of its ownK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
  8. Descendant · 2 generations on · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
  9. Descendant · 3 generations on · 2 of its ownK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
  10. Descendant · 4 generations on · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 22016: 12019: 12020: 12021: 12022: 1
2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007 · cites it directly6descendants
  • K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007 · 2 generations on5descendants
  • K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · 2 generations on4descendants
  • K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019 · 3 generations on2descendants
  • K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201610
201910
202010
202110
202210
FIG. 1 — Lineage of K061963, 1996–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K060116Micrus Courier Microcatheters
Summary page 1
…iagnostic Regulatory Class II Predicate Device: Micrus Microcatheter, "Courier" Straight, 5 10O(k) number K0601 16 Boston Scientific, Excelsior 10 18 and SL-1I0 Microcatheters, 5 10(k) numnb…
Micrus Endovascular Corporation2006—
*K042568Excelsior 1018 and SL-10 Microcatheters
Summary page 1
…5 10O(k) number K0601 16 Boston Scientific, Excelsior 10 18 and SL-1I0 Microcatheters, 5 10(k) numnber K042568 Device Description: The Micrus Microcatheters are tubular devices with a single lumen designed…
Boston Scientific Corp20047

Also cleared against K060116: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation20076

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 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K070456 (Micrus Endovascular Corporation, 2007) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K060116.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

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.

Also cleared against K060116

5 other devices cite the same predicate.

  • K113819Mongoose Angiographic CatheterPediacath, Inc. · 2012
  • K112828Revive Intermediate Catheter (Revive IC)Codman & Shurtleff, Inc. · 2011
  • K092702Micrus Microcatheter, Model Courier 270Micrus Endovascular Corporation · 2009
  • K083922Micrus Microcatheter, Courier Flex, Model MSF 170000-00Micrus Endovascular Corporation · 2009
  • K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008

More from Micrus Endovascular Corporation

23 FDA decisions under this applicant name. See the company

  • K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon Catheter 6X9 MM; Micrus…Micrus Endovascular Corporation · 2011
  • K102818Micrus One 2 One Guidewire, Micrus One 2 One Soft GuidewireMicrus Endovascular Corporation · 2010
  • K092702Micrus Microcatheter, Model Courier 270Micrus Endovascular Corporation · 2009
  • K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon Catheter 4X10MM,4X15…Micrus Endovascular Corporation · 2009
  • K083922Micrus Microcatheter, Courier Flex, Model MSF 170000-00Micrus Endovascular Corporation · 2009

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/K061963 · printed Nov 3, 2026

Cite this page

510(k) Report. “K061963: Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061963

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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