510(k) Report

510(k) · Cleared

Cleared

Graftsaver

K043515510(k) TraditionalCleared Mar 31, 2005101-day reviewClass I21 CFR 878.4200

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

Vescare, Inc. · GBX Catheter, Irrigation

Cleared on Mar 31, 2005 as substantially equivalent to K000704 (Dmc Medical, Ltd., 2000) after a 101-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.

Decided
Mar 31, 2005
Review
101 days
Class
Class I
Product code
GBX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000704 (2000). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2019: 1 descendant clearedK000704 · DMC Saphenous Vein Distention System (SVDS) · Dmc Medical, Ltd. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K000704 · DMC Saphenous Vein Distention System (SVDS) · Dmc Medical, Ltd. · 20000
  1. Root · 1 generation backK000704 DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000
  2. This deviceK043515 GraftsaverVescare, Inc. · 2005
  3. Descendant · cites it directly · 5 of its ownK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
  6. Descendant · 3 generations on · 0 of its ownK140603 Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK131659 Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12011: 12014: 22019: 1
2008high 2 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · cites it directly5descendants
  • K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · 2 generations on2descendants
  • K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC · 2019 · 3 generations on0descendants
  • K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · 3 generations on0descendants
  • K131659Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000704DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd.2000—
0 (this device)K043515GraftsaverVescare, Inc.2005—
+1K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC20081
+2K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC20091
+3K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar…Maquet Cardiovascular, LLC2019—
+3K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc.20141
+2K131659Moerae Vein Preparation KitMoerae Matrix, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201110
201420
201910
FIG. 1 — Lineage of K043515, 2000–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GBX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K000704DMC Saphenous Vein Distention System (SVDS)
Summary page 1
…re distention. Substantial Equivalence: This device is substantially equivalent to the DMC Saphenous Vein Distention System by DMC medical limited per K000704 cleared on May 19, 2000. Public…
Dmc Medical, Ltd.2000—

Also cleared against K000704: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC20085

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?

  • Its one ancestor has no recall.
  • Of its descendants, K082725 (Maquet Cardiovascular, LLC, 2008) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K000704.

How does its category compare?

All GBX devices

GBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBX

1in 2014

2008: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBX

Too few GBX 510(k)s in any year since 2007 to give a median.

Recalls per year · GBX

6in 2025

2010: 12017: 12021: 12022: 292025: 6
2007high 29 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GBX

1,179in 2025

2007: 112008: 162009: 242010: 352011: 412012: 462013: 492014: 512015: 582016: 862017: 1762018: 2772019: 1962020: 1982021: 3832022: 4772023: 6282024: 9452025: 1,179
2007high 1,179 (2025) · low 11 (2007)2025

MAUDE reports naming product code GBX, 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
20070—011
20081—016
20090—024
20100—135
20110—041
20120—046
20130—049
20141—051
20150—058
20160—086
20170—1176
20180—0277
20190—0196
20200—0198
20210—1383
20220—29477
20230—0628
20240—0945
20250—61,179
20260—0—

What is it indicated for?

The device is indicated for use in the distention and irrigation of venous vessels prior to use as a

bspass graft.

Indications for use as stated in the FDA summary.

Also cleared against K000704

2 other devices cite the same predicate.

  • K131659Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014
  • K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 20081 recall

Recent decisions in GBX

The GBX category page

  • K131659Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014
  • K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 20081 recall
  • K052286Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
  • K013417Misonix Irrigation System Moedl BC20PMisonix, Inc. · 2002
  • K000704DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000

https://510kreport.com/device/K043515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043515: Graftsaver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043515

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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