510(k) · Cleared

Cleared

Gore Hybrid Vascular Graft

K093934510(k) TraditionalCleared Mar 17, 201085-day reviewClass II21 CFR 870.3450

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

W.L. Gore & Associates · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Mar 17, 2010 as substantially equivalent to K062161 (W. L. Gore & Associates, Inc., 2006) and 3 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1983.

Decided: Mar 17, 2010
Review: 85 days
Class: Class II
Product code: DSY
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K830806 (1983). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK830806 Vascular Graft/Bifurcated/Fep-RingedW. L. Gore & Associates, Inc. · 1983
1 generation backK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · Recalled
This deviceK093934 Gore Hybrid Vascular GraftW.L. Gore & Associates · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K830806	Vascular Graft/Bifurcated/Fep-Ringed	W. L. Gore & Associates, Inc.	1983	—
−1	K062161	Gore Propaten Vascular Graft	W. L. Gore & Associates, Inc.	2006	2
0 (this device)	K093934	Gore Hybrid Vascular Graft	W.L. Gore & Associates	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1993	1	0
2002	1	0
2005	1	0
2007	1	0

FIG. 1 — Lineage of K093934, 1983–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DSY? 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 DSY device

#1 K252445 Fusion Bioline Vascular Graftscore 12.5 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K062161	Gore Propaten Vascular Graft Summary page 2 …lly Equivalent Devices W.L. Gore & Associates cites the following devices as substantially equivalent predicate devices listed below: • GORE PROPATEN8 Vascular Graft (K062161) Cleared November 9, 2006 * GORE VIABA1HN® Endoprosthesis (K013648) Cleared January 8, 2002 * ATRIUM Graduated Wall Flixen…	W. L. Gore & Associates, Inc.	2006	2
*	K013648	Viabahn Endoprosthesis Summary page 2 …ces as substantially equivalent predicate devices listed below: • GORE PROPATEN8 Vascular Graft (K062161) Cleared November 9, 2006 * GORE VIABA1HN® Endoprosthesis (K013648) Cleared January 8, 2002 * ATRIUM Graduated Wall Flixene Graft (K071923) Cleared August 14, 2007 * ATRIUM Advanta T-Graft…	W. L. Gore & Associates, Inc.	2002	—
*	K071923	Ptfe Flixene Graduated Wall Graft Summary page 2 …OPATEN8 Vascular Graft (K062161) Cleared November 9, 2006 * GORE VIABA1HN® Endoprosthesis (K013648) Cleared January 8, 2002 * ATRIUM Graduated Wall Flixene Graft (K071923) Cleared August 14, 2007 * ATRIUM Advanta T-Graft (K051332) Cleared September 29, 2005 Brief Comparison Summary To demonstra…	Atrium Medical Corp.	2007	18
*	K051332	Advanta T-Graft Summary page 2 …GORE VIABA1HN® Endoprosthesis (K013648) Cleared January 8, 2002 * ATRIUM Graduated Wall Flixene Graft (K071923) Cleared August 14, 2007 * ATRIUM Advanta T-Graft (K051332) Cleared September 29, 2005 Brief Comparison Summary To demonstrate substantial equivalence of the applicant GORE HYBRID Vascula…	Atrium Medical Corp.	2005	1

Also cleared against K062161: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 27 years and passes through 2 companies; a new generation was cleared every 23.2 years on median.
3 of the 7 ancestors have a recall of any class.
3 other devices also cite its predicate K062161.

How does its category compare?

All DSY devices

DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DSY

2in 2025

2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2007high 269 (2017) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSY

1in 2025

2007high 5 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DSY

151in 2025

2007high 460 (2015) · low 120 (2007)2025

MAUDE reports naming product code DSY, 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	1	—	0	120
2008	1	—	0	164
2009	5	73	2	193
2010	4	55	5	187
2011	1	—	0	165
2012	4	30	0	177
2013	5	69	1	207
2014	2	—	0	352
2015	1	—	0	460
2016	1	—	2	217
2017	3	269	0	193
2018	1	—	0	200
2019	1	—	0	232
2020	1	—	0	169
2021	2	—	0	168
2022	2	—	0	155
2023	2	—	0	149
2024	5	160	0	153
2025	2	—	1	151
2026	1	—	1	—

What is it indicated for?

The GORE HYBRID Vascular Graft is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093934 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093934: Gore Hybrid Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093934

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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