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)

Reprocessed IntellaMap Orion High Resolution Mapping Catheter

K-Number: K211662 · 2021-11-18

ApplicantInnovative Health, LLC
Decision Date2021-11-18
Product CodeNLG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed IntellaMap Orion High Resolution Mapping Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2021-11-18 under approval number K211662. The device is classified under product code NLG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed IntellaMap Orion High Resolution Mapping Catheter?

Reprocessed IntellaMap Orion High Resolution Mapping Catheter is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Innovative Health, LLC. The 510(k) number is K211662.

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

Reprocessed IntellaMap Orion High Resolution Mapping Catheter received FDA 510(k) clearance on 2021-11-18, under approval number K211662.

What company makes Reprocessed IntellaMap Orion High Resolution Mapping Catheter?

Reprocessed IntellaMap Orion High Resolution Mapping Catheter is manufactured by Innovative Health, LLC.

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

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

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 Innovative Health, LLC

K162251Reprocessed Viking Diagnostic Electrophysiology Catheters K161827Reprocessed Response Diagnostic Electrophysiology Catheters K161769Reprocessed Supreme Diagnostic Electrophysiology Catheters K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

View all 48 devices →

Related Devices (Code: NLG)

K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative 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.

↑