510(k) · Cleared
ClearedVenaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impra, Inc. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cleared on May 7, 1998 after a 44-day review. The FDA summary names its predicate without a number.
- Decided
- May 7, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- DYF
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | — | Venaflo ePTFE Vascular Graft Named without a submission number | |
| * | — | IMPRA Carboflo Vascular Graft Named without a submission number |
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 devicesDYF 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
MAUDE reports naming product code DYF, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Venaflo Grafts with Carbon are indicated for subcutaneous arteriovenous conduit for blood access only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981076: Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo 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/K981076
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026