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FDA 510(k)

Dragonfly OpStar™ Imaging Catheter

K-Number: K230411 · 2023-04-14

ApplicantABBOTT MEDICAL
Decision Date2023-04-14
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dragonfly OpStar™ Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K230411. 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 Dragonfly OpStar™ Imaging Catheter?

Dragonfly OpStar™ Imaging Catheter is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K230411.

When did Dragonfly OpStar™ Imaging Catheter receive FDA 510(k) clearance?

Dragonfly OpStar™ Imaging Catheter received FDA 510(k) clearance on 2023-04-14, under 510(k) number K230411.

Who is the listed applicant for Dragonfly OpStar™ Imaging Catheter?

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

What is the FDA product code for Dragonfly OpStar™ Imaging Catheter?

The FDA product code for Dragonfly OpStar™ Imaging Catheter is DQO.

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Related Devices (Code: DQO)

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.

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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