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FDA 510(k)

EDM(R) INFUSION CATHETER

K-Number: K914979 · 1992-09-16

ApplicantPeripheral Systems Group
Decision Date1992-09-16
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDM(R) INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Peripheral Systems Group. It received FDA 510(k) clearance on 1992-09-16 under 510(k) number K914979. 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 EDM(R) INFUSION CATHETER?

EDM(R) INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1992-09-16. The listed applicant is Peripheral Systems Group. The 510(k) number is K914979.

When did EDM(R) INFUSION CATHETER receive FDA 510(k) clearance?

EDM(R) INFUSION CATHETER received FDA 510(k) clearance on 1992-09-16, under 510(k) number K914979.

Who is the listed applicant for EDM(R) INFUSION CATHETER?

The FDA 510(k) record lists Peripheral Systems Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDM(R) INFUSION CATHETER?

The FDA product code for EDM(R) 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 Peripheral Systems Group 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.

K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONK934433VANTAGE DIALTAION CATHETERK932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETERK931327PSG DIRECTIONAL HYDROPHILIC GUIDE WIREK915554HI-TORQUE SPORT-T(TM) GUIDE WIREK913941PSG(TM) 20 GUAGE DOPPLER NEEDLE

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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.

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