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FDA 510(k)

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter

K-Number: K191880 · 2019-12-11

ApplicantInnovative Health, LLC
Decision Date2019-12-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K191880. 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 Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Innovative Health, LLC. The 510(k) number is K191880.

When did Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter receive FDA 510(k) clearance?

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2019-12-11, under 510(k) number K191880.

Who is the listed applicant for Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

The FDA product code for Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is DRF.

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.

NCT01254474Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential CatheterCOMPLETED

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Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation

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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