510(k) Report

510(k) · Cleared

Cleared

Amplatzer Vascular Plug 4

K113658510(k) TraditionalCleared Jun 12, 2012183-day reviewClass II21 CFR 870.3300

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

Aga Medical Corp. · KRD Device, Vascular, For Promoting Embolization

Cleared on Jun 12, 2012 as substantially equivalent to K071125 (Aga Medical Corp., 2007) and 1 other predicate after a 183-day review. Its family tree reaches back 8 generations to 1989. 13 later devices descend from it.

Decided
Jun 12, 2012
Review
183 days
Class
Class II
Product code
KRD
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K891688 (1989). 17 ancestors in all. 13 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 3 other ancestors1995: 1 other ancestor1994: 2 other ancestors1990: 2 other ancestors1991: 1 other ancestor2013: 2 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2025: 1 descendant cleared2015: 2 descendants cleared2019: 1 descendant cleared2026: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant clearedK891688 · Coil and Coil Delivery System · Target Therapeutics · 1989K964367 · Ces Vascular Occlusion System · Cordis Neurovascular, Inc. · 1997K972881 · Ces Vascular Occlusion System · Cordis Neurovascular, Inc. · 1998K983483 · Vascular Occlusion System · Cordis Neurovascular, Inc. · 1999K993455 · Flipper Detachable Embolization Coil · Cook, Inc. · 2000K031810 · Amplatzer Vascular Plug · Aga Medical Corp. · 2003 · recalled×2: 2 generations cleared close together, K071125 (2007), K071699 (2007) 1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 5 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants K071699 · Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022 · Aga Medical Corp. · 2007K071125 · Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 · Aga Medical Corp. · 2007K031810 · Amplatzer Vascular Plug · Aga Medical Corp. · 2003 · recalledK993455 · Flipper Detachable Embolization Coil · Cook, Inc. · 2000K983483 · Vascular Occlusion System · Cordis Neurovascular, Inc. · 1999K972881 · Ces Vascular Occlusion System · Cordis Neurovascular, Inc. · 1998K964367 · Ces Vascular Occlusion System · Cordis Neurovascular, Inc. · 1997K891688 · Coil and Coil Delivery System · Target Therapeutics · 1989−50
  1. Root · 8 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
  2. 7 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
  3. 6 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
  4. 5 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
  5. 4 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
  6. 3 generations backK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
  7. 2 generations backK071125 Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008…Aga Medical Corp. · 2007
  8. 1 generation backK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007
  9. This deviceK113658 Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
  10. Descendant · cites it directly · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  11. Descendant · 2 generations on · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  12. Descendant · 2 generations on · 5 of its ownK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
  13. Descendant · 2 generations on · 4 of its ownK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
  14. Descendant · cites it directly · 2 of its ownK133924 Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 22014: 22015: 22018: 12019: 12020: 12022: 22025: 12026: 1
2013high 2 (2013) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all
  • K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · cites it directly10descendants
  • K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 2 generations on6descendants
  • K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014 · 2 generations on5descendants
  • K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015 · 2 generations on4descendants
  • K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K891688Coil and Coil Delivery SystemTarget Therapeutics1989—
−7K964367Ces Vascular Occlusion SystemCordis Neurovascular, Inc.1997—
−6K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc.1998—
−5K983483Vascular Occlusion SystemCordis Neurovascular, Inc.1999—
−4K993455Flipper Detachable Embolization CoilCook, Inc.2000—
−3K031810Amplatzer Vascular PlugAga Medical Corp.20031
−2K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010…Aga Medical Corp.2007—
−1K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.2007—
0 (this device)K113658Amplatzer Vascular Plug 4Aga Medical Corp.2012—
+1K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation2013—
+2K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation2013—
+2K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation2014—
+2K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation2015—
+1K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199110
199420
199510
199630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201420
201520
201810
201910
202010
202220
202510
202610
FIG. 1 — Lineage of K113658, 1989–2026Source: 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), 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 KRD? 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? (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
*K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…
Summary page 1
…1,21 CFR 870.3300 Product Code KIRD PeiaeAMPLATZER® Vascular Plug II Predicate Device Intended Use Preice 510(k) K071125, Reg. No. (K071125 and K071699): Devces870.3300; Product Code: KIRD…
Aga Medical Corp.2007—
*K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022
Summary page 1
…ATZER® Vascular Plug II Predicate Device Intended Use Preice 510(k) K071125, Reg. No. (K071125 and K071699): Devces870.3300; Product Code: KIRD The AMPLATZER® Vascular Plug is A…
Aga Medical Corp.2007—

Also cleared against K071125: 2 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310
K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142
K250133HARBOR Occlusion DeviceNuvascular, Inc.20251
K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181

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 23 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
  • 3 of the 17 ancestors have a recall of any class.
  • Of its descendants, K123803 (Reverse Medical Corporation, 2013) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K071125.

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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K071125

2 other devices cite the same predicate.

  • K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014
  • K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp. · 2007

More from Aga Medical Corp.

14 FDA decisions under this applicant name. See the company

  • K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120, Modeltv-2-07F120Aga Medical Corp. · 2010
  • K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp. · 2009
  • K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100Aga Medical Corp. · 2009
  • K080994Amplatzer Torqvue Exchange SystemAga Medical Corp. · 2008
  • K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008

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/K113658 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113658: Amplatzer Vascular Plug 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113658

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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