Product code DSY: 510(k) clearances and predicates
Product code DSY covers GORE® PROPATEN® Vascular Graft. FDA lists 188 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
188 clearances on file under product code DSY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 so far | 1 |
Recent clearances
Newest DSY clearances in the FDA index, with applicant and decision date:
- K252445, Fusion Bioline Vascular Graft, applicant Maquet Cardiovascular, LLC, decided 2026-04-27. FDA record
- K252277, Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645), applicant Vascular Flow Technologies Limited, decided 2025-10-20. FDA record
- K241550, Gelweave Vascular Prostheses, applicant Vascutek, Ltd., decided 2025-02-27. FDA record
- K241070, Gelsoft Plus Vascular Prostheses, applicant Vascutek, Ltd., decided 2024-11-15. FDA record
- K231972, Advanta VXT Vascular Graft, Flixene Vascular Graft, applicant Atrium Medical Corporation, decided 2024-03-28. FDA record
- K240083, GORE® PROPATEN® Vascular Graft, applicant W. L. Gore & Associates, Inc., decided 2024-03-01. FDA record
- K233783, exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts, applicant Peca Labs, Inc., decided 2024-01-17. FDA record
- K232312, GORE® PROPATEN® Vascular Graft, applicant W. L. Gore & Associates, Inc., decided 2024-01-09. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Fusion Bioline Vascular Graft, Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645). Watch new DSY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DSY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DSY clearances include GORE® PROPATEN® Vascular Graft.
How many 510(k) clearances use product code DSY?
188 at the time this page was generated, from openFDA records.
How do I find a predicate device under DSY?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DSY clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for DSY, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free DSY brief
Tell us where to send it. No card required.
You are on the list.
We will email your free DSY brief shortly. DSY is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.