DISTAFLO BYPASS GRAFT— 510(k) K983861

Clearance details

Applicant

Impra, Inc.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

1998-11-02

Decision date

1998-11-24

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Tempe, AZ, US

• 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

• K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS2001-05-14
• K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS2001-03-27
• K991027 — BI-DIRECTIONAL TUNNELER1999-04-22
• K983769 — DISTAFLO BYPASS GRAFT1998-12-15
• K983064 — IMPRA HIGH POROSITY GRAFT1998-11-19

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 →

• Z-0785-2016 — Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.Class II·Terminated·Bard Peripheral Vascular Inc·20160105
• Z-0786-2016 — Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.Class II·Terminated·Bard Peripheral Vascular Inc·20160105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983861.