PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452— 510(k) K984182

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K984182 for PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452, Substantially Equivalent on 1999-02-01. Applicant: Possis Medical, Inc..

Clearance details

Applicant: Possis Medical, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1998-11-23
Decision date: 1999-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.