510(k) · Cleared

Cleared

Perma-Pass Vascular Graft, 5T Graft,Model 31451

K984183510(k) TraditionalCleared Feb 1, 199970-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

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

Cleared on Feb 1, 1999 as substantially equivalent to K791810 (Impra, Inc., 1979) after a 70-day review. Its family tree reaches back 1 generation to 1979.

Decided: Feb 1, 1999
Review: 70 days
Class: Class II
Product code: DYF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K791810 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
This deviceK984183 Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K791810	Vascular Graft Prost. of Expanded Ptfe	Impra, Inc.	1979	—
0 (this device)	K984183	Perma-Pass Vascular Graft, 5T Graft,Model 31451	Possis Medical, Inc.	1999	—

FIG. 1 — Lineage of K984183, 1979–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K791810	Vascular Graft Prost. of Expanded Ptfe Summary page 1 …CLASS Vascular Graft prosthesis of less than 6 mm diameter (74DYF, 21 CFR 870.3450) LEGALLY MARKETED IMPRA ePTFE Vascular Graft PREDICATE DEVICE Straight; 5 mm x 50 cm K791810 IMPRA, Inc. 1625 West Third Street Tempe, Arizona 85281 38 DEVICE DESCRIPTION The Perma-Pass™ Vascular Graft i…	Impra, Inc.	1979	—

Also cleared against K791810: 4 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?

Its one ancestor has no recall.
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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	5
2008	—	4
2009	—	2
2010	—	6
2011	—	9
2012	—	2
2013	—	16
2014	—	7
2015	—	12
2016	—	35
2017	—	18
2018	—	6
2019	—	5
2020	—	7
2021	—	5
2022	—	9
2023	—	8
2024	—	6
2025	—	3
2026	—	—

What is it indicated for?

The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

Thinwall Perma-Pass Grafts are not indicated for blood access.

Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

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/K984183 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984183: Perma-Pass Vascular Graft, 5T Graft,Model 31451.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984183

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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