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 Eagle Eye Platinum RX Digital IVUS Catheter

K-Number: K210655 · 2022-05-25

ApplicantInnovative Health, LLC
Decision Date2022-05-25
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2022-05-25 under approval number K210655. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Innovative Health, LLC. The 510(k) number is K210655.

When was Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter approved by the FDA?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance on 2022-05-25, under approval number K210655.

What company makes Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is OWQ.

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: OWQ)

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersSterilmed, Inc. K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, 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.

↑