R2P Metacross RX— 510(k) K163479

Substantially Equivalent

KANEKA Corporation

FDA 510(k) clearance K163479 for R2P Metacross RX, Substantially Equivalent on 2017-01-11. Applicant: KANEKA Corporation.

Clearance details

Applicant: KANEKA Corporation
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2016-12-12
Decision date: 2017-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.