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

FDA 510(k)

CLOSED FLUID COLLECTION SYSTEM

K-Number: K961147 · 1996-05-31

ApplicantB.Braun Medical, Inc.
Decision Date1996-05-31
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED FLUID COLLECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1996-05-31 under 510(k) number K961147. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOSED FLUID COLLECTION SYSTEM?

CLOSED FLUID COLLECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-31. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K961147.

When did CLOSED FLUID COLLECTION SYSTEM receive FDA 510(k) clearance?

CLOSED FLUID COLLECTION SYSTEM received FDA 510(k) clearance on 1996-05-31, under 510(k) number K961147.

Who is the listed applicant for CLOSED FLUID COLLECTION SYSTEM?

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

What is the FDA product code for CLOSED FLUID COLLECTION SYSTEM?

The FDA product code for CLOSED FLUID COLLECTION SYSTEM is GBX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing B.Braun Medical, Inc. as applicant

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.

K254111Irrigation/Urology SetsK253235Introcan Safety® Deep Access XL IV CatheterK243392Infusomat® Space Volumetric Infusion Pump Administration SetsK240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemK241845Introcan Safety® 2 IV CatheterK241385Omnifix Syringe NRFit

View all 142 devices →

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, Inc.

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.

↑