510(k) Report

510(k) · Cleared

Cleared

Fasguide

K951159510(k) TraditionalCleared Sep 25, 1995195-day reviewClass II21 CFR 870.1250

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

Target Therapeutics · DQY Catheter, Percutaneous

Cleared on Sep 25, 1995 after a 195-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 152 devices in its family, counting itself, has a Class I recall. 151 later devices descend from it.

Decided
Sep 25, 1995
Review
195 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

151 later devices descend from it, 1 citing it directly. 1 of the 152 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 6 descendants cleared2000: 3 descendants cleared1999: 1 descendant cleared2004: 3 descendants cleared2001: 1 descendant cleared2003: 3 descendants cleared2006: 1 descendant cleared2010: 7 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2011: 9 descendants cleared2013: 11 descendants cleared2017: 6 descendants cleared2012: 11 descendants cleared2014: 7 descendants cleared2015: 8 descendants cleared2020: 3 descendants cleared2016: 7 descendants cleared2018: 5 descendants cleared2022: 7 descendants cleared, 1 with a Class I recall12019: 2 descendants cleared2021: 6 descendants cleared2024: 4 descendants cleared2025: 5 descendants cleared2023: 2 descendants cleared2026: 6 descendants cleared1995200020052010201520202025
  1. This deviceK951159 FasguideTarget Therapeutics · 1995
  2. Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  3. Descendant · 2 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  4. Descendant · 2 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
  5. Descendant · 3 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
  6. Descendant · 2 generations on · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000

Showing 5 of 151 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12000: 32001: 12002: 62003: 32004: 32005: 32006: 12007: 52008: 82009: 102010: 72011: 92012: 112013: 112014: 72015: 82016: 72017: 62018: 52019: 22020: 32021: 62022: 72023: 22024: 42025: 52026: 6
1997high 11 (2012) · low 0 (1998)2026

Class I recalls in this family

  • K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…7 generations on · 2022

Most influential descendants

Showing 5 of 151 · See all
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
  • K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 2 generations on138descendants
  • K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 2 generations on105descendants
  • K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 3 generations on103descendants
  • K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · 2 generations on98descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951159FasguideTarget Therapeutics1995—
+1K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
+2K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
+2K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch…Boston Scientific, Target2000—
+3K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002—
+2K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi…Boston Scientific, Target2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200030
200110
200260
200330
200430
200530
200610
200750
200880
2009100
201070
201190
2012110
2013110
201470
201580
201670
201760
201850
201920
202030
202160
202271
202320
202440
202550
202660
FIG. 1 — Lineage of K951159, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (151)

See all 151

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

NumberDeviceApplicantDecidedDescendants
K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K971395 (Target Therapeutics, 1997) has gone furthest, with 150 descendants of its own.

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)—

More from Target Therapeutics

70 FDA decisions under this applicant name. See the company

  • K965071Detachable Slicone Balloon (DSB)Target Therapeutics · 1998
  • K964488Detachable Silicone Balloon (DSB)Target Therapeutics · 1998
  • K964210Retriever IITarget Therapeutics · 1997
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum…Target Therapeutics · 1997
  • K965189SpinnakerTarget Therapeutics · 1997

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The DQY category page

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https://510kreport.com/device/K951159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951159: Fasguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951159

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026