510(k) · Cleared
Recalled · 2009Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 20, 2004 as substantially equivalent to K030512 (Guidant Corp., 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1994. 3 of the 26 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945975 (1994). 10 ancestors in all, the oldest K904993 (1991). 15 later devices descend from it, 6 citing it directly. 3 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 2 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 1 generation backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- This deviceK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004
- Descendant · cites it directly · 7 of its ownK052274 Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model…Guidant Corporation · 2005 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK101274 Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK233879 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2024
- Descendant · cites it directly · 2 of its ownK092789 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · Recalled
- Descendant · cites it directly · 2 of its ownK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · cites it directly7descendants
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · cites it directly4descendants
- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2024 · 2 generations on2descendants
- K092789Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · cites it directly2descendants
- K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −2 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −1 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| 0 (this device) | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | — |
| +1 | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 | Guidant Corporation | 2005 | Class I |
| +1 | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2010 | Class I |
| +2 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview… | Maquet Cardiovascular, LLC | 2024 | — |
| +1 | K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corp. | 2010 | 2 |
| +1 | K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | Maquet Cardiovascular, LLC | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting SystemSummary page 1…bstantial Guidant VasoView 6 Harvesting Cannula are substantially equivalent with equivalence regard to these features in the predicate devices: the VV4 (K030512, May 14, 2003), VV5 (K020143, February 20, 2002), and VV6 (K022718, August 28, 2002).… | 2003 |
| * | K020143 | Vasoview 5 Harvesting CannulaSummary page 1…annula are substantially equivalent with equivalence regard to these features in the predicate devices: the VV4 (K030512, May 14, 2003), VV5 (K020143, February 20, 2002), and VV6 (K022718, August 28, 2002).… | 2002 |
| * | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Summary page 1…th equivalence regard to these features in the predicate devices: the VV4 (K030512, May 14, 2003), VV5 (K020143, February 20, 2002), and VV6 (K022718, August 28, 2002).… | 2002 |
What descends from it? (15)
See all 156 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 Class I | 2005 | 7 |
| K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Class I | 2010 | 4 |
| K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | 2010 | 2 |
| K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | 2009 | 2 |
| K140008 | Virtuosaph Plus Endoscopic Vessel Harvesting System | 2014 | 1 |
| K062050 | Flexview System | 2006 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2009 | Not classified | Z-3270-2011 | Nonconforming Material/Component | During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices. |
| Dec 17, 2009 | Not classified | Z-3271-2011 | Nonconforming Material/Component | During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices. |
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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K052274 (Guidant Corporation, 2005) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K030512.
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 VasoView® 6 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other…
Read the full statement (130 words)
The VasoView® 6 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. 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/K041981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041981
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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