MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT— 510(k) K955460

Substantially Equivalent - Subject to Tracking Reg.

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K955460 for MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT, Substantially Equivalent - Subject to Tracking Reg. on 1996-05-30. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1995-11-29
Decision date: 1996-05-30
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

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.