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FDA 510(k)

Royal Flush Plus High-Flow Catheter

K-Number: K180054 · 2018-10-05

ApplicantCook Incorporated
Decision Date2018-10-05
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Royal Flush Plus High-Flow Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K180054. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Royal Flush Plus High-Flow Catheter?

Royal Flush Plus High-Flow Catheter is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is Cook Incorporated. The 510(k) number is K180054.

When did Royal Flush Plus High-Flow Catheter receive FDA 510(k) clearance?

Royal Flush Plus High-Flow Catheter received FDA 510(k) clearance on 2018-10-05, under 510(k) number K180054.

Who is the listed applicant for Royal Flush Plus High-Flow Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Royal Flush Plus High-Flow Catheter?

The FDA product code for Royal Flush Plus High-Flow Catheter is DQO.

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Related Devices (Code: DQO)

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K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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