510(k) · Cleared
ClearedPerma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater 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
- DSY
- 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.
- Root · 1 generation backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- This deviceK984182 Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452Possis 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) | K984182 | Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452 | Possis Medical, Inc. | 1999 | — |
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 DSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSY device
- #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K791810 | Vascular Graft Prost. of Expanded PtfeSummary page 1…LASS Vascular Graft prosthesis of 6 mm and greater diameter (74DSY, 21 CFR 870.3460) LEGALLY MARKETED IMPRA ePTFE Vascular Graft PREDICATE DEVICE Straight; 6 mm x 50 cm K791810 IMPRA, Inc. 1625 West Third Street Tempe, Arizona 85281 DEVICE DESCRIPTION The Perma-Pass™ Vascular Graft is man… | 1979 |
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 DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, 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 | 1 | — | 0 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
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/K984182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984182: Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984182
Report an extraction error
Are you the manufacturer?
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