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)

MICROFUSE MEMBRANE INFUSION CATHETER

K-Number: K971619 · 1998-02-27

ApplicantE-Med Corp.
Decision Date1998-02-27
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICROFUSE MEMBRANE INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is E-Med Corp.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K971619. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROFUSE MEMBRANE INFUSION CATHETER?

MICROFUSE MEMBRANE INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is E-Med Corp.. The 510(k) number is K971619.

When did MICROFUSE MEMBRANE INFUSION CATHETER receive FDA 510(k) clearance?

MICROFUSE MEMBRANE INFUSION CATHETER received FDA 510(k) clearance on 1998-02-27, under 510(k) number K971619.

Who is the listed applicant for MICROFUSE MEMBRANE INFUSION CATHETER?

The FDA 510(k) record lists E-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROFUSE MEMBRANE INFUSION CATHETER?

The FDA product code for MICROFUSE MEMBRANE INFUSION CATHETER is KRA.

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 E-Med Corp. 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.

K843200SITE STRIPK792049I.V. STRIP

Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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.

↑