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FDA 510(k)

Reprocessed Inquiry Steerable Diagnostic EP Catheter

K-Number: K171277 · 2017-10-23

ApplicantInnovative Health, LLC
Decision Date2017-10-23
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Inquiry Steerable Diagnostic EP Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2017-10-23 under approval number K171277. 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 Inquiry Steerable Diagnostic EP Catheter?

Reprocessed Inquiry Steerable Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Innovative Health, LLC. The 510(k) number is K171277.

When was Reprocessed Inquiry Steerable Diagnostic EP Catheter approved by the FDA?

Reprocessed Inquiry Steerable Diagnostic EP Catheter received FDA 510(k) clearance on 2017-10-23, under approval number K171277.

What company makes Reprocessed Inquiry Steerable Diagnostic EP Catheter?

Reprocessed Inquiry Steerable Diagnostic EP Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Inquiry Steerable Diagnostic EP Catheter?

The FDA product code for Reprocessed Inquiry Steerable Diagnostic EP Catheter is DRF.

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Other Devices by Innovative Health, LLC

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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 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.

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