Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rapid Barostat Bag (RBB) Pump and Catheter

K-Number: K160287 · 2017-03-14

ApplicantMui Scientific
Decision Date2017-03-14
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rapid Barostat Bag (RBB) Pump and Catheter is a medical device manufactured by Mui Scientific. It received FDA 510(k) clearance on 2017-03-14 under approval number K160287. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Barostat Bag (RBB) Pump and Catheter?

Rapid Barostat Bag (RBB) Pump and Catheter is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Mui Scientific. The 510(k) number is K160287.

When was Rapid Barostat Bag (RBB) Pump and Catheter approved by the FDA?

Rapid Barostat Bag (RBB) Pump and Catheter received FDA 510(k) clearance on 2017-03-14, under approval number K160287.

What company makes Rapid Barostat Bag (RBB) Pump and Catheter?

Rapid Barostat Bag (RBB) Pump and Catheter is manufactured by Mui Scientific.

What is the FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter?

The FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter is FFX.

Related Clinical Trials

NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT07523750 A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation RECRUITING NCT03065335 Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder RECRUITING

Related PubMed Literature

PMID: 31926779 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety. The Journal of emergency medicine (2020)

Related Devices (Code: FFX)

K160170Lehman Manometry CatheterWilson-Cook Medical, Inc. K160725EndoFLIPCrospon, Ltd. K151086ManoScan SystemGiven Imaging , Ltd. K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd. K181750SITZMARKSKonsyl Pharmaceuticals K191087IntraMarX Radiopaque MarkersAnx Robotica Corp

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑