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FDA 510(k)

Advisor HD Grid Mapping Catheter, Sensor Enabled

K-Number: K172393 · 2018-04-23

ApplicantSt. Jude Medical, Inc.
Decision Date2018-04-23
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device manufactured by St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2018-04-23 under approval number K172393. 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 Advisor HD Grid Mapping Catheter, Sensor Enabled?

Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2018-04-23. It is manufactured by St. Jude Medical, Inc.. The 510(k) number is K172393.

When was Advisor HD Grid Mapping Catheter, Sensor Enabled approved by the FDA?

Advisor HD Grid Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2018-04-23, under approval number K172393.

What company makes Advisor HD Grid Mapping Catheter, Sensor Enabled?

Advisor HD Grid Mapping Catheter, Sensor Enabled is manufactured by St. Jude Medical, Inc..

What is the FDA product code for Advisor HD Grid Mapping Catheter, Sensor Enabled?

The FDA product code for Advisor HD Grid Mapping Catheter, Sensor Enabled is MTD.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING

Other Devices by St. Jude Medical, Inc.

K161171PressureWire X Guidewire K161102Nanostim Introducer Kit K160716The Nanostim Introducer Kit K163407Confirm Rx Insertable Cardiac Monitor (ICM) System PMA P880006Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Related Devices (Code: MTD)

K153093FIRMap CatheterAbbott Electrophysiology K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K163709FIRMap CatheterAbbott Electrophysiology K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.

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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