Rapid Barostat Bag (RBB) Pump and Catheter— 510(k) K160287

Substantially Equivalent

Mui Scientific

FDA 510(k) clearance K160287 for Rapid Barostat Bag (RBB) Pump and Catheter, Substantially Equivalent on 2017-03-14. Applicant: Mui Scientific.

Clearance details

Applicant: Mui Scientific
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-03
Decision date: 2017-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

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.