BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT— 510(k) K933590

Name: FDA 510(k) clearance K933590
Creator: U.S. Food and Drug Administration
Published: 1994-01-26

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K933590 for BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT, Substantially Equivalent on 1994-01-26. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1993-07-26
Decision date: 1994-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

view all

K252445 — Fusion Bioline Vascular Graft2026-04-27
K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)2025-10-20
K241550 — Gelweave Vascular Prostheses2025-02-27
K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

More clearances from Baxter Healthcare Corp

view all

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.