PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240— 510(k) K092040

Substantially Equivalent

R4 Vascular, Inc.

FDA 510(k) clearance K092040 for PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240, Substantially Equivalent on 2009-11-18. Applicant: R4 Vascular, Inc..

Clearance details

Applicant: R4 Vascular, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2009-07-02
Decision date: 2009-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.