HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC— 510(k) K955349

Substantially Equivalent

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K955349 for HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC, Substantially Equivalent on 1996-02-14. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1995-11-21
Decision date: 1996-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.