FDA product code · Cardiovascular · Class 2
DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
DSY is FDA's product code for "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter": a Class 2 device classified under 21 CFR 870.3450, reviewed by the Cardiovascular panel. FDA flags it as an implant.
510(k) review time for DSY
Across 17 510(k) clearances under DSY decided from 2018-01-01 to 2026-10-06, the median was 131 days from FDA receipt to decision. Half took between 59 and 210 days, and 80% were decided within 241 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 59 |
| Median | 131 |
| 75th percentile | 210 |
| 80th percentile | 241 |
| 90th percentile | 267 |
| Slowest | 272 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
DSY in the public FDA record
| 510(k) clearances, all years | 188 |
|---|---|
| Device recalls | 86 |
| Establishment listings | 115 |
| GUDID device identifiers | 3,682 |
Counts of records, not of devices or events. Adverse event reports for DSY are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite DSY
2 FDA recognized consensus standards cite DSY, among them ISO 7198 Second edition 2016-08-01; ISO 25539-4 First edition 2021-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-144 ISO 7198 Second edition 2016-08-01 — Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
- 3-197 ISO 25539-4 First edition 2021-11 — Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.