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FDA 510(k)

EP DEFLECTABLE CATHETERS

K-Number: K033963 · 2004-04-15

ApplicantEp Medsystems, Inc.
Decision Date2004-04-15
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP DEFLECTABLE CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medsystems, Inc.. It received FDA 510(k) clearance on 2004-04-15 under 510(k) number K033963. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP DEFLECTABLE CATHETERS?

EP DEFLECTABLE CATHETERS is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is Ep Medsystems, Inc.. The 510(k) number is K033963.

When did EP DEFLECTABLE CATHETERS receive FDA 510(k) clearance?

EP DEFLECTABLE CATHETERS received FDA 510(k) clearance on 2004-04-15, under 510(k) number K033963.

Who is the listed applicant for EP DEFLECTABLE CATHETERS?

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

What is the FDA product code for EP DEFLECTABLE CATHETERS?

The FDA product code for EP DEFLECTABLE CATHETERS is DRF.

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 Ep Medsystems, 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.

K063277MAPMATEK994011EP MEDSYSTEMS, EP-WORKMATE

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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