510(k) Report

510(k) · Cleared

Recalled · 2003

Fibered Platinum Coil, .035 Type

K955293510(k) TraditionalCleared Feb 6, 199682-day reviewClass II21 CFR 870.3300Recalls 2

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

Target Therapeutics · KRD Device, Vascular, For Promoting Embolization

Cleared on Feb 6, 1996 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 193 devices in its family, counting itself, has a Class I recall. 192 later devices descend from it. It has been recalled 2 times.

Decided
Feb 6, 1996
Review
82 days
Class
Class II
Product code
KRD
Recalls
2
Predicates
0

192 later devices descend from it, 6 citing it directly. 1 of the 193 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2011: 15 descendants cleared1999: 2 descendants cleared2003: 4 descendants cleared2000: 4 descendants cleared2013: 14 descendants cleared2005: 4 descendants cleared2007: 7 descendants cleared2025: 8 descendants cleared2002: 6 descendants cleared2006: 2 descendants cleared2018: 5 descendants cleared2008: 10 descendants cleared2015: 10 descendants cleared2014: 8 descendants cleared2012: 14 descendants cleared2016: 9 descendants cleared2026: 10 descendants cleared2004: 3 descendants cleared2001: 1 descendant cleared2010: 8 descendants cleared2009: 12 descendants cleared2021: 7 descendants cleared2020: 4 descendants cleared2019: 2 descendants cleared2017: 6 descendants cleared2022: 8 descendants cleared, 1 with a Class I recall12024: 5 descendants cleared2023: 3 descendants cleared1995200020052010201520202025
  1. This deviceK955293 Fibered Platinum Coil, .035 TypeTarget Therapeutics · 1996
  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 192 descendants. See all descendants

Descendants cleared per year

1997: 11999: 22000: 42001: 12002: 62003: 42004: 32005: 42006: 22007: 72008: 102009: 122010: 82011: 152012: 142013: 142014: 82015: 102016: 92017: 62018: 52019: 22020: 42021: 72022: 82023: 32024: 52025: 82026: 10
1997high 15 (2011) · 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 192 · 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)K955293Fibered Platinum Coil, .035 TypeTarget Therapeutics1996—
+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
199920
200040
200110
200260
200340
200430
200540
200620
200770
2008100
2009120
201080
2011150
2012140
2013140
201480
2015100
201690
201760
201850
201920
202040
202170
202281
202330
202450
202580
2026100
FIG. 1 — Lineage of K955293, 1996–2026Source: 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), 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 KRD device

  1. #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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?

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

What descends from it? (192)

See all 192

6 later devices cite 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
K993455Flipper Detachable Embolization CoilCook, Inc.200041
K031810Amplatzer Vascular PlugAga Medical Corp.200338
K992121Embolization Coil SystemCook, Inc.19994
K110295Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp20113
K102714Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils…Boston Scientific Corp20110

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 23, 2003Not classifiedZ-1033-03OtherProduct 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
Jun 23, 2003Not classifiedZ-1034-03OtherProduct 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

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 KRD devices

KRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRD

9in 2025

2007: 22008: 52009: 42010: 32011: 52012: 82013: 112014: 72015: 112016: 42017: 42018: 42019: 62020: 42021: 32022: 82023: 22024: 62025: 92026 (partial year): 7
2007high 11 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRD

60in 2025

2008: 84 days median2009: 27 days median2010: 150 days median2011: 36 days median2012: 30 days median2013: 33 days median2014: 134 days median2015: 130 days median2016: 164 days median2017: 89 days median2018: 62 days median2019: 178 days median2020: 137 days median2021: 134 days median2022: 175 days median2024: 70 days median2025: 60 days median2026 (partial year): 70 days median
2007high 178 (2019) · low 27 (2009)2026

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

Recalls per year · KRD

1in 2024

2010: 12013: 12023: 12024: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRD

1,572in 2025

2007: 212008: 142009: 402010: 612011: 1022012: 1372013: 2442014: 1592015: 3372016: 4372017: 7362018: 1,0662019: 1,1852020: 1,1672021: 1,4442022: 1,4982023: 1,3712024: 1,5352025: 1,572
2007high 1,572 (2025) · low 14 (2008)2025

MAUDE reports naming product code KRD, 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
20072—021
2008584014
2009427040
20103150161
20115360102
20128300137
201311331244
201471340159
2015111300337
201641640437
20174890736
201846201,066
2019617801,185
2020413701,167
2021313401,444
2022817501,498
20232—11,371
202467011,535
202596001,572
20267701—

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

Recent decisions in KRD

The KRD category page

  • K262798LOBO Vascular Occlusion SystemOkami Medical, Inc. · 2026
  • K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd. · 2026
  • K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
  • K261866Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026
  • K260635HARBOR Occlusion DeviceNuvascular, Inc. · 2026

https://510kreport.com/device/K955293 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955293: Fibered Platinum Coil, .035 Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955293

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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