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FDA 510(k)

Rapid Barostat Bag (RBB) Pump and Catheter System

K-Number: K262621 · 2026-09-30

ApplicantMui Scientific, Inc.
Decision Date2026-09-30
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rapid Barostat Bag (RBB) Pump and Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Mui Scientific, Inc.. It received FDA 510(k) clearance on 2026-09-30 under 510(k) number K262621. 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 System?

Rapid Barostat Bag (RBB) Pump and Catheter System is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Mui Scientific, Inc.. The 510(k) number is K262621.

When did Rapid Barostat Bag (RBB) Pump and Catheter System receive FDA 510(k) clearance?

Rapid Barostat Bag (RBB) Pump and Catheter System received FDA 510(k) clearance on 2026-09-30, under 510(k) number K262621.

Who is the listed applicant for Rapid Barostat Bag (RBB) Pump and Catheter System?

The FDA 510(k) record lists Mui Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx 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.

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