510(k) Report

510(k) · Cleared

Cleared

Impra Carboflo Eptfe Vascular Grafts

K004012510(k) TraditionalCleared May 14, 2001138-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 May 14, 2001 after a 138-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 14, 2001
Review
138 days
Class
Class II
Product code
DYF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K004012Source: FDA 510(k) database · 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?

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.

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

  • 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
  • K983064Impra High Porosity GraftImpra, Inc. · 1998

Recent decisions in DYF

The DYF category page

  • 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
  • K984183Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc. · 1999

https://510kreport.com/device/K004012 · printed Nov 4, 2026

Cite this page

510(k) Report. “K004012: Impra Carboflo Eptfe Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K004012

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