510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Excelsior 1018 and SL-10 Microcatheters

K042568510(k) SpecialCleared Oct 15, 200424-day reviewClass II21 CFR 870.1250Recalls 7

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

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on Oct 15, 2004 as substantially equivalent to K994155 (Boston Scientific, Target, 2000) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1996. 25 later devices descend from it. It has been recalled 7 times.

Decided
Oct 15, 2004
Review
24 days
Class
Class II
Product code
DQY
Recalls
7
Predicates
2

Its longest line of descent runs back 3 generations to K960806 (1996). 4 ancestors in all, the oldest K925813 (1994). 25 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2018: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared2013: 3 descendants cleared2023: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2024: 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K013789 · 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+5
  1. Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 2 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 1 generation backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. This deviceK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004
  5. Descendant · cites it directly · 8 of its ownK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
  6. Descendant · cites it directly · 7 of its ownK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
  7. Descendant · 2 generations on · 6 of its ownK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
  8. Descendant · 3 generations on · 5 of its ownK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
  9. Descendant · 3 generations on · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22010: 22012: 12013: 32015: 22016: 12017: 22018: 12019: 22020: 12021: 22022: 12023: 12024: 12025: 12026: 1
2006high 3 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 25 · See all
  • K113778Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · cites it directly8descendants
  • K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation · 2006 · cites it directly7descendants
  • K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007 · 2 generations on6descendants
  • K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007 · 3 generations on5descendants
  • K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960806Turbo TrackerTarget Therapeutics1996—
−2K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−1K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
0 (this device)K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp2004—
+1K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20123
+1K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation2006—
+2K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation2007—
+3K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation2007—
+3K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
201020
201210
201330
201520
201610
201720
201810
201920
202010
202120
202210
202310
202410
202510
202610
FIG. 1 — Lineage of K042568, 1996–2026Source: 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*K994155Excelsior 1018 Microcatheter
Summary page 1
…sion coils to the peripheral, coronary, and such as contrast media, and therapeutic neuro vasculature. Predicate Device s): Excelsior 1018 Microcatheter (5 10(k) # K994155 cleared August 3, 2000) TM Excelsior SL-10 Microcatheter (510 (k) # K013789 cleared December 6, 2001)…
Boston Scientific, Target2000—
*K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189
Summary page 1
…re. Predicate Device s): Excelsior 1018 Microcatheter (5 10(k) # K994155 cleared August 3, 2000) TM Excelsior SL-10 Microcatheter (510 (k) # K013789 cleared December 6, 2001) Testing in Support of Substantial Equivalence Determination…
Boston Scientific, Target20012

Also cleared against K994155: 3 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20128
K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation20067
K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.20103
K100826Penumbra Catherer 025Penumbra, Inc.20102
K210601Plato 17 MicrocatheterScientia Vascular, LLC20211
K173548Merit Pursue MicrocatheterMerit Medical Systems, Inc.20180

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 4, 2013Class IIZ-0497-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0494-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0499-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0495-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0496-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0500-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Nov 4, 2013Class IIZ-0501-2014Software Manufacturing/Software DeploymentProducts were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K113778 (Stryker Neurovascular, 2012) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate K994155.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

Boston Scientific's Excelsior' SL-10 Pre-Shaped Microcatheter and Excelsior' 1018' Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K994155

3 other devices cite the same predicate.

  • K123452Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17 Microcatheter, 150 CM Long…Stryker · 2013
  • K050599Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp · 2005
  • K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 20012 recalls

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The DQY category page

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https://510kreport.com/device/K042568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042568: Excelsior 1018 and SL-10 Microcatheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042568

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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