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FDA 510(k)

ARRHYTHMIA MAPPING SYSTEM (8100/8300)

K-Number: K965066 · 1997-08-11

ApplicantCardiac Pathways Corp.
Decision Date1997-08-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA MAPPING SYSTEM (8100/8300) is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pathways Corp.. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K965066. 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 ARRHYTHMIA MAPPING SYSTEM (8100/8300)?

ARRHYTHMIA MAPPING SYSTEM (8100/8300) is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Cardiac Pathways Corp.. The 510(k) number is K965066.

When did ARRHYTHMIA MAPPING SYSTEM (8100/8300) receive FDA 510(k) clearance?

ARRHYTHMIA MAPPING SYSTEM (8100/8300) received FDA 510(k) clearance on 1997-08-11, under 510(k) number K965066.

Who is the listed applicant for ARRHYTHMIA MAPPING SYSTEM (8100/8300)?

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

What is the FDA product code for ARRHYTHMIA MAPPING SYSTEM (8100/8300)?

The FDA product code for ARRHYTHMIA MAPPING SYSTEM (8100/8300) 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 Cardiac Pathways 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.

K992912CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATHK990795MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLESK982540MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,K983653RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D

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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