MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F— 510(k) K062887

Substantially Equivalent

Bard Peripheral Vascular

FDA 510(k) clearance K062887 for MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F, Substantially Equivalent on 2006-10-26. Applicant: Bard Peripheral Vascular.

Clearance details

Applicant: Bard Peripheral Vascular
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2006-09-26
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, 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.