Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IntellaMap Orion High Resolution Mapping Catheter

K-Number: K220796 · 2022-06-10

ApplicantBoston Scientific Corporation
Decision Date2022-06-10
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IntellaMap Orion High Resolution Mapping Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-06-10 under approval number K220796. 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 IntellaMap Orion High Resolution Mapping Catheter?

IntellaMap Orion High Resolution Mapping Catheter is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K220796.

When was IntellaMap Orion High Resolution Mapping Catheter approved by the FDA?

IntellaMap Orion High Resolution Mapping Catheter received FDA 510(k) clearance on 2022-06-10, under approval number K220796.

What company makes IntellaMap Orion High Resolution Mapping Catheter?

IntellaMap Orion High Resolution Mapping Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for IntellaMap Orion High Resolution Mapping Catheter?

The FDA product code for IntellaMap Orion High Resolution Mapping Catheter is DRF.

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 Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

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 K153139Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. K160390Map-it Diagnostic Mapping CathetersAccess Point Technologies Ep, 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.

↑