STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM— 510(k) K964284

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K964284 for STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM, Substantially Equivalent on 1997-01-06. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1996-10-28
Decision date: 1997-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

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Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.