510(k) Report

510(k) · Cleared

Cleared

Meadox Medicals, Inc. Expanded Ptfe Vascular Graft

K960766510(k) TraditionalCleared Mar 19, 1997387-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

Meadox Medicals, Div. Boston Scientific Corp. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Cleared on Mar 19, 1997 as substantially equivalent to K791810 (Impra, Inc., 1979) and 5 other predicates after a 387-day review. Its family tree reaches back 1 generation to 1979. 12 later devices descend from it.

Decided
Mar 19, 1997
Review
387 days
Class
Class II
Product code
DYF
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K791810 (1979). 6 ancestors in all. 12 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1988: 1 other ancestor1983: 1 other ancestor1982: 1 other ancestor1981: 1 other ancestor2006: 1 descendant cleared2013: 2 descendants cleared2008: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant clearedK791810 · Vascular Graft Prost. of Expanded Ptfe · Impra, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K791810 · Vascular Graft Prost. of Expanded Ptfe · Impra, Inc. · 19790+5
  1. Root · 1 generation backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
  2. This deviceK960766 Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  3. Descendant · cites it directly · 11 of its ownK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
  5. Descendant · 3 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
  6. Descendant · 3 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
  7. Descendant · 3 generations on · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12012: 22013: 22016: 12017: 12021: 12022: 12026: 1
2006high 2 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp · 2006 · cites it directly11descendants
  • K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · 2 generations on7descendants
  • K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009 · 3 generations on6descendants
  • K120006Hero GraftHemosphere, Inc. · 2012 · 3 generations on5descendants
  • K121532Hero GraftHemosphere, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K791810Vascular Graft Prost. of Expanded PtfeImpra, Inc.1979—
0 (this device)K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.1997—
+1K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted…Boston Scientific Corp20063
+2K071778Hero Vascular Access DeviceGraftcath, Inc.2008—
+3K091491Hero Vascular Access DeviceHemosphere, Inc.2009—
+3K120006Hero GraftHemosphere, Inc.2012—
+3K121532Hero GraftHemosphere, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198210
198310
198810
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201220
201320
201610
201710
202110
202210
202610
FIG. 1 — Lineage of K960766, 1979–2026Source: 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 DYF? 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
Get a 510(k) Report

What was it cleared against? (9)

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
*K791810Vascular Graft Prost. of Expanded Ptfe
Summary page 1
…MATERIALS: MANUFACTURING: SPECIFICATIONS: CONCLUSION: Preamendment | GORE-TEX® Vascular Grat W.L. Gore & Associates Preamendment | IMPRA® Vascular Graft IMPRA, Inc. K79 1810 IMPRA® Vascular Graft ) IMPRA, Inc. K81 1510 GORE-TEX® FEP Ringed Vascular Graft W.L. Gore & Associates K82 1716 Bard® PTFE Vascu…
Impra, Inc.1979—
*K811510Gore-Tex Vasular Graft
Summary page 1
…CONCLUSION: Preamendment | GORE-TEX® Vascular Grat W.L. Gore & Associates Preamendment | IMPRA® Vascular Graft IMPRA, Inc. K79 1810 IMPRA® Vascular Graft ) IMPRA, Inc. K81 1510 GORE-TEX® FEP Ringed Vascular Graft W.L. Gore & Associates K82 1716 Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 08…
W. L. Gore & Associates, Inc.1981—
*K821716Bard Ptfe Vascular Prosthesis
Summary page 1
…ciates Preamendment | IMPRA® Vascular Graft IMPRA, Inc. K79 1810 IMPRA® Vascular Graft ) IMPRA, Inc. K81 1510 GORE-TEX® FEP Ringed Vascular Graft W.L. Gore & Associates K82 1716 Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 | GORE-TEX® Vascular Graft - W.L. Gore & Associates _W—[ GORE-TEX…
C.R. Bard, Inc.1982—
*K830806Vascular Graft/Bifurcated/Fep-Ringed
Summary page 1
…0 IMPRA® Vascular Graft ) IMPRA, Inc. K81 1510 GORE-TEX® FEP Ringed Vascular Graft W.L. Gore & Associates K82 1716 Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 | GORE-TEX® Vascular Graft - W.L. Gore & Associates _W—[ GORE-TEX® Stretch Vascular Graft W.L. Gore & Associates K88 0167 | GORE-…
W. L. Gore & Associates, Inc.1983—
*K880167Gore-Tex Vascular Graft
Summary page 1
…TFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 | GORE-TEX® Vascular Graft - W.L. Gore & Associates _W—[ GORE-TEX® Stretch Vascular Graft W.L. Gore & Associates K88 0167 | GORE-TEX® Removable FEP Ring Graft W.L. Gore & Associates K93 3590 | Baxter Reinforced Expanded PTFE Graft Baxter Healthcare, C…
W. L. Gore & Associates, Inc.1988—
*K933590Baxter Reinforced Expanded Ptfe Vascular Graft
Summary page 1
…Vascular Graft - W.L. Gore & Associates _W—[ GORE-TEX® Stretch Vascular Graft W.L. Gore & Associates K88 0167 | GORE-TEX® Removable FEP Ring Graft W.L. Gore & Associates K93 3590 | Baxter Reinforced Expanded PTFE Graft Baxter Healthcare, Corp. The ePTFE yz,n0x Vascular Graft is comprised of an expanded pol…
Baxter Healthcare Corp1994—
*—GORE-TEX® Vascular Graft
Named without a submission number
—
*—IMPRA® Vascular Graft
Named without a submission number
—
*—GORE-TEX® Stretch Vascular Graft
Named without a submission number
—

Also cleared against K791810: 4 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp200611

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K052964 (Boston Scientific Corp, 2006) has gone furthest, with 11 descendants of its own.
  • 4 other devices also cite its predicate K791810.

How does its category compare?

All DYF devices

DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYF

FDA has decided no DYF device since 2007.

Median 510(k) review, days · DYF

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

Recalls per year · DYF

No recall names DYF since 2007.

Adverse event reports per year · DYF

3in 2025

2007: 52008: 42009: 22010: 62011: 92012: 22013: 162014: 72015: 122016: 352017: 182018: 62019: 52020: 72021: 52022: 92023: 82024: 62025: 3
2007high 35 (2016) · low 2 (2009)2025

MAUDE reports naming product code DYF, 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—05
20080—04
20090—02
20100—06
20110—09
20120—02
20130—016
20140—07
20150—012
20160—035
20170—018
20180—06
20190—05
20200—07
20210—05
20220—09
20230—08
20240—06
20250—03
20260—0—

What is it indicated for?

The ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K791810

4 other devices cite the same predicate.

  • K984182Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452Possis Medical, Inc. · 1999
  • K984183Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc. · 1999
  • K962433Meadox Exxcel Eptfe 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 Meadox Medicals, Div. Boston…

54 FDA decisions under this applicant name. See the company

  • K953647MS Classique Balloon Catheter W/Hydropass CoatingMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K961847Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 19971 recall
  • K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 19962 recalls
  • K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996

Recent decisions in DYF

The DYF category page

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K000504Advanta Super Soft GraftAtrium Medical Corp. · 20001 recall
  • K992958Advanta Graft (<6MM)Atrium Medical Corp. · 199915 recalls
  • K991683Ptfe Ringed Gore-Tex Vascular GraftW. L. Gore & Associates, Inc. · 1999
  • K992441Advanta GraftAtrium Medical Corp. · 19991 recall

https://510kreport.com/device/K960766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960766: Meadox Medicals, Inc. Expanded Ptfe 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/K960766

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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