FELT, SURGICAL DACRON— 510(k) K760516

Substantially Equivalent

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K760516 for FELT, SURGICAL DACRON, Substantially Equivalent on 1977-01-05. 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: 1976-08-25
Decision date: 1977-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.