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FDA 510(k)

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER

K-Number: K933417 · 1995-05-04

ApplicantEchocath, Inc.
Decision Date1995-05-04
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Echocath, Inc.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K933417. 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 ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER?

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Echocath, Inc.. The 510(k) number is K933417.

When did ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 1995-05-04, under 510(k) number K933417.

Who is the listed applicant for ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER?

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

What is the FDA product code for ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER?

The FDA product code for ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER 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 Echocath, 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.

K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1K990642ECHOFLOW DOPPLER BLOOD VELOCITY METERK932436ECHOMARK INTRAUTERINE GUIDING CATHETERK926351COLORMARK(TM) VISUALIZATION SYSTEMK922787ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

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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