510(k) Report

510(k) · Cleared

Cleared

Reverse Medical Micro Vascular Plug (MVP) System

K123803510(k) TraditionalCleared Jul 2, 2013204-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

Reverse Medical Corporation · KRD Device, Vascular, For Promoting Embolization

Cleared on Jul 2, 2013 as substantially equivalent to K113658 (Aga Medical Corp., 2012) and 4 other predicates after a 204-day review. Its family tree reaches back 13 generations to 1995. 10 later devices descend from it.

Decided
Jul 2, 2013
Review
204 days
Class
Class II
Product code
KRD
Recalls
None
Predicates
5

Its longest line of descent runs back 13 generations to K951256 (1995). 83 ancestors in all, the oldest K860840 (1986). 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 2 other ancestors2008: 2 other ancestors2000: 6 other ancestors2009: 1 other ancestor2007: 6 other ancestors2005: 5 other ancestors2004: 5 other ancestors2003: 9 other ancestors2002: 3 other ancestors1999: 1 other ancestor2006: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1996: 2 other ancestors1994: 5 other ancestors1990: 2 other ancestors2001: 1 other ancestor1992: 5 other ancestors1991: 3 other ancestors1989: 1 other ancestor1995: 2 other ancestors1988: 3 other ancestors1986: 1 other ancestor2014: 2 descendants cleared2013: 1 descendant cleared2015: 2 descendants cleared2022: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant clearedK951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995×2: 2 generations cleared close together, K960705 (1996), K962503 (1996) K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 1999K012145 · Microplex Coil System · MicroVention, Inc. · 2001K020434 · Microplex Coil System (MCS) · MicroVention, Inc. · 2002×2: 2 generations cleared close together, K032590 (2003), K033836 (2003) K041551 · Modification to: Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2004K050954 · Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2005 · recalledK071939 · Hydrocoil Embolic Systems (Hes) · MicroVention, Inc. · 2008K093002 · Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610 · MicroVention, Inc. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 14 other ancestors4 generations back: 19 other ancestors5 generations back: 11 other ancestors6 generations back: 15 other ancestors7 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants K093002 · Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610 · MicroVention, Inc. · 2009K071939 · Hydrocoil Embolic Systems (Hes) · MicroVention, Inc. · 2008K050954 · Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2005 · recalledK041551 · Modification to: Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2004K033836 · Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2003K032590 · Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2003K020434 · Microplex Coil System (MCS) · MicroVention, Inc. · 2002K012145 · Microplex Coil System · MicroVention, Inc. · 2001K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 1999K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K962503 · Guglielmi Detachable Coil · Target Therapeutics · 1996K960705 · Guglielmi Detachable Coil · Target Therapeutics · 1996K951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995−10−50
  1. Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 9 generations between
  3. 3 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
  4. 2 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
  5. 1 generation backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
  6. This deviceK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  7. Descendant · cites it directly · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  8. Descendant · cites it directly · 5 of its ownK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
  9. Descendant · cites it directly · 4 of its ownK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
  10. Descendant · cites it directly · 2 of its ownK133924 Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014
  11. Descendant · 2 generations on · 1 of its ownK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
Show all 13 generations
  1. Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 12 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
  3. 11 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
  4. 10 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  5. 9 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  6. 8 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
  7. 7 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
  8. 6 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  9. 5 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  10. 4 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
  11. 3 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
  12. 2 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
  13. 1 generation backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
  14. This deviceK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22015: 22018: 12019: 12020: 12022: 2
2013high 2 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · cites it directly6descendants
  • K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014 · cites it directly5descendants
  • K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015 · cites it directly4descendants
  • K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014 · cites it directly2descendants
  • K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical · 2018 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K951256Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics1995—
−12K960705Guglielmi Detachable CoilTarget Therapeutics1996—
−11K962503Guglielmi Detachable CoilTarget Therapeutics1996—
−10K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
−9K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
−8K012145Microplex Coil SystemMicroVention, Inc.2001—
−7K020434Microplex Coil System (MCS)MicroVention, Inc.2002—
−6K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−5K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−4K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.2004—
−3K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.200516
−2K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.2008—
−1K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35…MicroVention, Inc.2009—
0 (this device)K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation2013—
+1K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation2013—
+1K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation2014—
+1K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation2015—
+1K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.2014—
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198830
198910
199020
199130
199250
199450
199520
199620
199720
199810
199910
200060
200110
200230
200390
200450
200550
200610
200760
200820
200910
201020
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201520
201810
201910
202010
202220
FIG. 1 — Lineage of K123803, 1995–2022Source: 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 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? (5)

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
*K113658Amplatzer Vascular Plug 4
Summary page 1
…Name of Predicate Manufacturer 510(k) Number Devices AMPLATZERO Vascular Plug 4 AGA Corporation K113658 Plymouth, MN Azur Peripheral HydroCoil MicroVention, Inc. Endovascular…
Aga Medical Corp.2012—
*K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…
Summary page 1
…Plymouth, MN Azur Peripheral HydroCoil MicroVention, Inc. Endovascular Embolization Tustin, CA K093002 System - Detachable 35 Axium Detachable Coil System ev3 Endlovascular, Inc. K081465…
MicroVention, Inc.2009—
*K081465Axium Detachable Coil System
Summary page 1
…ascular Embolization Tustin, CA K093002 System - Detachable 35 Axium Detachable Coil System ev3 Endlovascular, Inc. K081465 Irvine, CA InZone Detachment System Boston Scientific, Inc K(10300…
Micro Therapeutics, Inc.20082
*K103008Inzone Detachment System
Summary page 1
…ev3 Endlovascular, Inc. K081465 Irvine, CA InZone Detachment System Boston Scientific, Inc K(103008 with the IZDS Connecting Cable Freemont, CA Guglielmi Detachable Coil Boston Scientific, Inc 1018…
Boston Scientific Corp2010—
*K001083Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables…
Summary page 2
…Coil Power Supply 510(k) No. K(123803 Class 11 K(113658 Class II K(093002 Class 11 K(081465 Class 11 K(103008 Class II K(001083 Class 11 KRD 870:3300 KRD 870:3300 KRD 870:3300 KRD 870:3300 KRD 87…
Boston Scientific, Target2000—

Also cleared against K113658: 3 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136
K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145
K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154
K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142

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 18 years and passes through 4 companies; a new generation was cleared every 12 months on median.
  • 14 of the 83 ancestors have a recall of any class.
  • Of its descendants, K133282 (Reverse Medical Corporation, 2013) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K113658.

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. 2013, 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 Reverse Medical™ Micro Vascular Plug (MVP™) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K123803: Reverse Medical Micro Vascular Plug (MVP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123803

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026