510(k) Report

510(k) · Cleared

Cleared

Vascular Graft Prost. of Expanded Ptfe

K791810510(k) TraditionalCleared Oct 9, 197925-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

Impra, Inc. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Cleared on Oct 9, 1979 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
Oct 9, 1979
Review
25 days
Class
Class II
Product code
DYF
Recalls
None
Predicates
0

17 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1997: 2 descendants cleared1996: 1 descendant cleared2006: 1 descendant cleared2013: 2 descendants cleared2016: 1 descendant cleared2008: 1 descendant cleared2026: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
  2. Descendant · cites it directly · 13 of its ownK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
  3. Descendant · cites it directly · 12 of its ownK960766 Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  4. Descendant · cites it directly · 12 of its ownK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  5. Descendant · 2 generations on · 11 of its ownK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
  6. Descendant · 3 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1996: 11997: 21999: 22006: 12008: 12009: 12012: 22013: 22016: 12017: 12021: 12022: 12026: 1
1996high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 17 · See all
  • K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly13descendants
  • K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · cites it directly12descendants
  • K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · cites it directly12descendants
  • K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp · 2006 · 2 generations on11descendants
  • K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K791810Vascular Graft Prost. of Expanded PtfeImpra, Inc.1979—
+1K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular…Meadox Medicals, Div. Boston Scientific Corp.1996—
+1K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.1997—
+1K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.1997—
+2K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted…Boston Scientific Corp20063
+3K071778Hero Vascular Access DeviceGraftcath, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
199920
200610
200810
200910
201220
201320
201610
201710
202110
202210
202610
FIG. 1 — Lineage of K791810, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199613
K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199712
K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199712
K984182Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452Possis Medical, Inc.19990
K984183Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc.19990

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?

  • Of its descendants, K955460 (Meadox Medicals, Div. Boston Scientific Corp., 1996) has gone furthest, with 13 descendants of its own.

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—

More from Impra, Inc.

29 FDA decisions under this applicant name. See the company

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K004011Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V AccessImpra, Inc. · 2001
  • K991027BI-Directional TunnelerImpra, Inc. · 1999
  • K983769Distaflo Bypass GraftImpra, Inc. · 1998
  • K983861Distaflo Bypass GraftImpra, Inc. · 19982 recalls

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/K791810 · printed Nov 5, 2026

Cite this page

510(k) Report. “K791810: Vascular Graft Prost. of Expanded Ptfe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791810

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026