BI-DIRECTIONAL TUNNELER— 510(k) K991027

Name: FDA 510(k) clearance K991027
Creator: U.S. Food and Drug Administration
Published: 1999-04-22

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K991027 for BI-DIRECTIONAL TUNNELER, Substantially Equivalent on 1999-04-22. Applicant: Impra, Inc.. Device class: 2.

Clearance details

Applicant: Impra, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1999-03-29
Decision date: 1999-04-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

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K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

More clearances from Impra, Inc.

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K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS2001-05-14
K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS2001-03-27
K983769 — DISTAFLO BYPASS GRAFT1998-12-15
K983861 — DISTAFLO BYPASS GRAFT1998-11-24
K983064 — IMPRA HIGH POROSITY GRAFT1998-11-19

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.