DISTAFLO BYPASS GRAFT— 510(k) K983861

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K983861 for DISTAFLO BYPASS GRAFT, Substantially Equivalent on 1998-11-24. Applicant: Impra, Inc..

Clearance details

Applicant: Impra, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1998-11-02
Decision date: 1998-11-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.