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FDA 510(k)

Achieve ST Mapping Catheter, Catheter Connecting Cable

K-Number: K153139 · 2016-05-06

ApplicantMedtronic, Inc.
Decision Date2016-05-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Achieve ST Mapping Catheter, Catheter Connecting Cable is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-05-06 under approval number K153139. 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 Achieve ST Mapping Catheter, Catheter Connecting Cable?

Achieve ST Mapping Catheter, Catheter Connecting Cable is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Medtronic, Inc.. The 510(k) number is K153139.

When was Achieve ST Mapping Catheter, Catheter Connecting Cable approved by the FDA?

Achieve ST Mapping Catheter, Catheter Connecting Cable received FDA 510(k) clearance on 2016-05-06, under approval number K153139.

What company makes Achieve ST Mapping Catheter, Catheter Connecting Cable?

Achieve ST Mapping Catheter, Catheter Connecting Cable is manufactured by Medtronic, Inc..

What is the FDA product code for Achieve ST Mapping Catheter, Catheter Connecting Cable?

The FDA product code for Achieve ST Mapping Catheter, Catheter Connecting Cable is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED 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 NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING

Other Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

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Related Devices (Code: DRF)

K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DSt Jude Medical K161769Reprocessed Supreme Diagnostic Electrophysiology CathetersInnovative Health, LLC K162892Achieve Advance Mapping CatheterMedtronic, Inc. K151139EasyMap MAP CatheterMedfact Engineering GmbH K160390Map-it Diagnostic Mapping CathetersAccess Point Technologies Ep, Inc. K171277Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC

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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