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FDA 510(k)

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

K-Number: K200212 · 2020-09-03

ApplicantInnovative Health, LLC
Decision Date2020-09-03
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled 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 2020-09-03 under 510(k) number K200212. 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 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled?

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Innovative Health, LLC. The 510(k) number is K200212.

When did Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-09-03, under 510(k) number K200212.

Who is the listed applicant for Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled?

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 Advisor HD Grid Mapping Catheter, Sensor Enabled?

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

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Related Devices (Code: MTD)

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.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, 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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