PTFE FELTS AND PLEDGETS— 510(k) K041716

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K041716 for PTFE FELTS AND PLEDGETS, Substantially Equivalent on 2004-07-22. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2004-06-24
Decision date: 2004-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, 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.