← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

DEVICE CLASS
Class II
REGULATION
21 CFR 870.3450
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252445Maquet Cardiovascular, LLC · 510k2026-04-27
K252277Vascular Flow Technologies Limited · 510k2025-10-20
K241550Vascutek, Ltd. · 510k2025-02-27
K241070Vascutek, Ltd. · 510k2024-11-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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