FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT— 510(k) K050832

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K050832 for FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT, Substantially Equivalent on 2005-07-07. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2005-04-01
Decision date: 2005-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

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Adverse events under product code JCT

product code JCT

Death: 20
Injury: 211
Other: 1
Total: 232

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.