510(k) · Cleared

Recalled · 2010

Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven

K052964510(k) TraditionalCleared Jan 6, 200677-day reviewClass II21 CFR 870.3450Recalls 3

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

Boston Scientific Corp · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Jan 6, 2006 as substantially equivalent to K955460 (Meadox Medicals, Div. Boston Scientific Corp., 1996) and 4 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1979. 11 later devices descend from it. It has been recalled 3 times.

Decided: Jan 6, 2006
Review: 77 days
Class: Class II
Product code: DSY
Recalls: 3
Predicates: 5

Its longest line of descent runs back 3 generations to K791810 (1979). 12 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
2 generations backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
1 generation backK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
This deviceK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006
Descendant · cites it directly · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
Descendant · 2 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
Descendant · 2 generations on · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012
Descendant · 2 generations on · 3 of its ownK124039 Hero GraftHemoshpere, Inc., A Cryolife Company · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2008high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · cites it directly7descendants
K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009 · 2 generations on6descendants
K120006Hero GraftHemosphere, Inc. · 2012 · 2 generations on5descendants
K121532Hero GraftHemosphere, Inc. · 2012 · 2 generations on4descendants
K124039Hero GraftHemoshpere, Inc., A Cryolife Company · 2013 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K791810	Vascular Graft Prost. of Expanded Ptfe	Impra, Inc.	1979	—
−2	K955460	Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular…	Meadox Medicals, Div. Boston Scientific Corp.	1996	—
−1	K962433	Meadox Exxcel Eptfe Vascular Graft	Meadox Medicals, Div. Boston Scientific Corp.	1997	—
0 (this device)	K052964	Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted…	Boston Scientific Corp	2006	—
+1	K071778	Hero Vascular Access Device	Graftcath, Inc.	2008	—
+2	K091491	Hero Vascular Access Device	Hemosphere, Inc.	2009	—
+2	K120006	Hero Graft	Hemosphere, Inc.	2012	—
+2	K121532	Hero Graft	Hemosphere, Inc.	2012	—
+2	K124039	Hero Graft	Hemoshpere, Inc., A Cryolife Company	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	2	0
1982	2	0
1983	1	0
1984	1	0
1988	1	0
1994	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2012	2	0
2013	2	0
2016	1	0
2017	1	0
2021	1	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K052964, 1979–2026Source: 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 12.4 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K955460	Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft Summary page 6 …h Enclosure Indications for Use 510(k) Number (ifknown): K052964 (covers vascular crafts previously cleared under K955460. K960766. K962433. K810845. K820696) Device Name: Standard Wall Exxcelm and ExxcelTM Soft ePTFE Vascular Grafts…	Meadox Medicals, Div. Boston Scientific Corp.	1996	—
*	K960766	Meadox Medicals, Inc. Expanded Ptfe Vascular Graft Summary page 6 …re Indications for Use 510(k) Number (ifknown): K052964 (covers vascular crafts previously cleared under K955460. K960766. K962433. K810845. K820696) Device Name: Standard Wall Exxcelm and ExxcelTM Soft ePTFE Vascular Grafts Mic…	Meadox Medicals, Div. Boston Scientific Corp.	1997	—
*	K962433	Meadox Exxcel Eptfe Vascular Graft Summary page 6 …age 6 === Indications for Use 510(k) Number (ifknown): K052964 (covers vascular crafts previously cleared under K955460. K960766. K962433. K810845. K820696) Device Name: Standard Wall Exxcelm and ExxcelTM Soft ePTFE Vascular Grafts MicrovelT m…	Meadox Medicals, Div. Boston Scientific Corp.	1997	—
*	K810845	Double Velour Grafts Summary page 6 …Indications for Use 510(k) Number (ifknown): K052964 (covers vascular crafts previously cleared under K955460. K960766. K962433. K810845. K820696) Device Name: Standard Wall Exxcelm and ExxcelTM Soft ePTFE Vascular Grafts MicrovelT m Double Ve…	Meadox Medicals, Div. Boston Scientific Corp.	1981	—
*	K820696	Meadox Woven Double Velour Summary page 6 …Indications for Use 510(k) Number (ifknown): K052964 (covers vascular crafts previously cleared under K955460. K960766. K962433. K810845. K820696) Device Name: Standard Wall Exxcelm and ExxcelTM Soft ePTFE Vascular Grafts MicrovelT m Double Velour Knit…	Meadox Medicals, Div. Boston Scientific Corp.	1982	—

Also cleared against K955460: 1 other device →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071778	Hero Vascular Access Device	Graftcath, Inc.	2008	7
K131778	Fusion Vascular Graft and Fusion Bioline Vascular Graft	Maquet Cardiovascular, LLC	2013	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 26, 2010	Not classified	Z-1606-2010	Labeling mix-ups	This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
Mar 26, 2010	Not classified	Z-1607-2010	Labeling mix-ups	This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
Jan 20, 2010	Not classified	Z-0866-2010	Labeling mix-ups	Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
None of the 12 ancestors has a recall.
Of its descendants, K071778 (Graftcath, Inc., 2008) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K955460.

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.

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 Standard Wall ExxcelTm and Exxcel Tm Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal. Infrageniculate Vessels, Axillary, Renal) and to provide vascular access.

Thin Wall Exxcel Tm soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal. Infrageniculate Vessels. Axillary. Renal).

The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052964

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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