510(k) Report

510(k) · Cleared

Cleared

Lifespan Eptfe Vascular Graft

K130016510(k) SpecialCleared Feb 5, 201335-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

LeMaitre Vascular, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Feb 5, 2013 as substantially equivalent to K933590 (Baxter Healthcare Corp, 1994) and 3 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1994.

Decided
Feb 5, 2013
Review
35 days
Class
Class II
Product code
DSY
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K933590 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK933590 · Baxter Reinforced Expanded Ptfe Vascular Graft · Baxter Healthcare Corp · 1994K032900 · Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts · Edwards Lifesciences, LLC · 2003199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K032900 · Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts · Edwards Lifesciences, LLC · 2003K933590 · Baxter Reinforced Expanded Ptfe Vascular Graft · Baxter Healthcare Corp · 19940
  1. Root · 2 generations backK933590 Baxter Reinforced Expanded Ptfe Vascular GraftBaxter Healthcare Corp · 1994
  2. 1 generation backK032900 Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally…Edwards Lifesciences, LLC · 2003
  3. This deviceK130016 Lifespan Eptfe Vascular GraftLeMaitre Vascular, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933590Baxter Reinforced Expanded Ptfe Vascular GraftBaxter Healthcare Corp1994—
−1K032900Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported…Edwards Lifesciences, LLC2003—
0 (this device)K130016Lifespan Eptfe Vascular GraftLeMaitre Vascular, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K130016, 1994–2013Source: 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 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. #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K933590Baxter Reinforced Expanded Ptfe Vascular Graft
Summary page 1
…scular graft prosthesis Classification Name: Prosthesis, Vascular Graft Predicate Devices: Baxter reinforced expanded PTFE vascular graft (K933590); Baxter reinforced expanded PTFE stepped vascular graft (K944844); Baxter ePTFE externally…
Baxter Healthcare Corp1994—
*K944844Baxter Reinforced Expanded Ptfe Stepped Vascular Graft
Summary page 1
…ices: Baxter reinforced expanded PTFE vascular graft (K933590); Baxter reinforced expanded PTFE stepped vascular graft (K944844); Baxter ePTFE externally supported vascular grafts (K944858); LifeSpan reinforced…
Baxter Healthcare Corp1995—
*K944858Baxter Eptfe Externally Supported Vascular Grafts
Summary page 1
…3590); Baxter reinforced expanded PTFE stepped vascular graft (K944844); Baxter ePTFE externally supported vascular grafts (K944858); LifeSpan reinforced ePTFE straight, externally supported, stepped vascular grafts…
Baxter Edwards1995—
*K032900Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular…
Summary page 1
…supported vascular grafts (K944858); LifeSpan reinforced ePTFE straight, externally supported, stepped vascular grafts (K032900) Device Description: LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is w…
Edwards Lifesciences, LLC2003—

Also cleared against K933590: 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 19 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
  • None of the 4 ancestors has a recall.
  • 3 other devices also cite its predicate K933590.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · DSY

2in 2025

2007: 12008: 12009: 52010: 42011: 12012: 42013: 52014: 22015: 12016: 12017: 32018: 12019: 12020: 12021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2009: 73 days median2010: 55 days median2012: 30 days median2013: 69 days median2017: 269 days median2024: 160 days median
2007high 269 (2017) · low 30 (2012)2026

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

Recalls per year · DSY

1in 2025

2009: 22010: 52013: 12016: 22025: 12026 (partial year): 1
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

2007: 1202008: 1642009: 1932010: 1872011: 1652012: 1772013: 2072014: 3522015: 4602016: 2172017: 1932018: 2002019: 2322020: 1692021: 1682022: 1552023: 1492024: 1532025: 151
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0120
20081—0164
20095732193
20104555187
20111—0165
20124300177
20135691207
20142—0352
20151—0460
20161—2217
201732690193
20181—0200
20191—0232
20201—0169
20212—0168
20222—0155
20232—0149
202451600153
20252—1151
20261—1—

What is it indicated for?

The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.

Indications for use as stated in the FDA summary.

Also cleared against K933590

3 other devices cite the same predicate.

  • K032900Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular…Edwards Lifesciences, LLC · 2003
  • K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996

More from LeMaitre Vascular, Inc.

75 FDA decisions under this applicant name. See the company

  • N16837/S040Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2026
  • N16837/S039Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2026
  • N16837/S036Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2025
  • N16837/S035Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2024
  • N16837/S034Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2024

Recent decisions in DSY

The DSY category page

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
  • K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 20251 recall
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 20241 recall
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

https://510kreport.com/device/K130016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130016: Lifespan Eptfe Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130016

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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