VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT— 510(k) K981079

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K981079 for VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT, Substantially Equivalent on 1998-05-07. Applicant: Impra, Inc..

Clearance details

Applicant: Impra, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1998-03-24
Decision date: 1998-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

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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.