BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J— 510(k) K052578

Unknown

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K052578 for BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J, Unknown on 2005-11-25. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2005-09-20
Decision date: 2005-11-25
Decision: Unknown
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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.