510(k) · Cleared
Recalled · Class II · 2023Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 28, 2009 as substantially equivalent to K041981 (Guidant Corporation, 2004) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945975 (1994). 15 ancestors in all, the oldest K853586 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 3 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 2 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 1 generation backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- This deviceK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009
- Descendant · cites it directly · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
- Descendant · cites it directly · 0 of its ownK140603 Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −3 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −2 | 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 |
| 0 (this device) | K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | Maquet Cardiovascular, LLC | 2009 | — |
| +1 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar… | Maquet Cardiovascular, LLC | 2019 | — |
| +1 | K140603 | Onepass Endoscopic Vessel Harvesting Sysyetm | Saphena Medical, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 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.
Planning a device in GEI? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…Summary page 1…PRO Endoscopic Vessel Harvesting System are substantially equivalence equivalent with regard to those features in the predicate device: the VV6 (K041981, August 20, 2004) and VASOSHIELD Pressure Controlling Syringe (K082725, December 17, 2008) Device Th… | 2004 |
| * | K082725 | Graftguard Pressure Controlling SyringeSummary page 1…ith regard to those features in the predicate device: the VV6 (K041981, August 20, 2004) and VASOSHIELD Pressure Controlling Syringe (K082725, December 17, 2008) Device The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System consists of the description VA… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2023 | Class II | Z-0210-2024 | Under Investigation by firm | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K191947 (Maquet Cardiovascular, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K041981.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 PRO 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 (156 words)
The VASOVIEW 6 PRO 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.
The VASOSHIELD Pressure Controlling Syringe is. indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091733: Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091733
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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