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FDA 510(k)

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES

K-Number: K990795 · 1999-06-08

ApplicantCardiac Pathways Corp.
Decision Date1999-06-08
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES 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 1999-06-08 under 510(k) number K990795. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES?

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES is a medical device that received FDA 510(k) clearance on 1999-06-08. The listed applicant is Cardiac Pathways Corp.. The 510(k) number is K990795.

When did MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES receive FDA 510(k) clearance?

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES received FDA 510(k) clearance on 1999-06-08, under 510(k) number K990795.

Who is the listed applicant for MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES?

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 MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES?

The FDA product code for MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES is MTD.

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 CATHK982540MERCATOR 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 DK965066ARRHYTHMIA MAPPING SYSTEM (8100/8300)

Related Devices (Code: MTD)

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.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, 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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