510(k) · Cleared
ClearedVasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation, Cardiac Surgery · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 28, 2002 as substantially equivalent to K020143 (Guidant Corporation, Cardiac Surgery, 2002) after a 13-day review. Its family tree reaches back 2 generations to 1994. 3 of the 20 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Aug 28, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945975 (1994). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 1 generation backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- This deviceK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- Descendant · cites it directly · 15 of its ownK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK052274 Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model…Guidant Corporation · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK101274 Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK233879 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK092789 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K041981Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…Guidant Corporation · 2004 · cites it directly15descendants
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · 2 generations on7descendants
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · 2 generations on4descendants
- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2024 · 3 generations on2descendants
- K092789Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −1 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| 0 (this device) | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| +1 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| +2 | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 | Guidant Corporation | 2005 | Class I |
| +2 | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2010 | Class I |
| +3 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview… | Maquet Cardiovascular, LLC | 2024 | — |
| +2 | K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corp. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 1 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 1 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
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.
3 devices in this family have 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020143 | Vasoview 5 Harvesting Cannula | 2002 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack… | 2004 | 15 |
Has anything in its family been recalled? (3 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.
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K041981 (Guidant Corporation, 2004) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K020143.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VasoViewO 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue…
Read the full statement (98 words)
The VasoViewO 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissectiodvessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022718: Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022718
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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