Rocket Platinum Cured Cathter— 510(k) K210509

Unknown

Rocket Medical Plc

FDA 510(k) clearance K210509 for Rocket Platinum Cured Cathter, Unknown on 2021-09-09. Applicant: Rocket Medical Plc.

Clearance details

Applicant: Rocket Medical Plc
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2021-02-22
Decision date: 2021-09-09
Decision: Unknown
Clearance type: Traditional
Location: Washington, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

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.