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)

FLUID ADMINISTRATION SET - CONTRAST MANAGER

K-Number: K961794 · 1996-08-01

ApplicantMerit Medical Systems, Inc.
Decision Date1996-08-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUID ADMINISTRATION SET - CONTRAST MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1996-08-01 under 510(k) number K961794. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID ADMINISTRATION SET - CONTRAST MANAGER?

FLUID ADMINISTRATION SET - CONTRAST MANAGER is a medical device that received FDA 510(k) clearance on 1996-08-01. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K961794.

When did FLUID ADMINISTRATION SET - CONTRAST MANAGER receive FDA 510(k) clearance?

FLUID ADMINISTRATION SET - CONTRAST MANAGER received FDA 510(k) clearance on 1996-08-01, under 510(k) number K961794.

Who is the listed applicant for FLUID ADMINISTRATION SET - CONTRAST MANAGER?

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

What is the FDA product code for FLUID ADMINISTRATION SET - CONTRAST MANAGER?

The FDA product code for FLUID ADMINISTRATION SET - CONTRAST MANAGER is FPA.

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 Merit Medical Systems, 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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetK262086PreludeSYNC™ Radial Compression DeviceK254073StatSeal DiscK251802STAR RF Ablation SystemK252892SCOUT MD Surgical Guidance SystemK250853Merit Syringe

View all 159 devices →

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑