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FDA 510(k)

Plato MICROCATH 27B Microcatheter

K-Number: K170406 · 2017-04-18

ApplicantScientia Vascular, LLC
Decision Date2017-04-18
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Plato MICROCATH 27B Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K170406. 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 Plato MICROCATH 27B Microcatheter?

Plato MICROCATH 27B Microcatheter is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K170406.

When did Plato MICROCATH 27B Microcatheter receive FDA 510(k) clearance?

Plato MICROCATH 27B Microcatheter received FDA 510(k) clearance on 2017-04-18, under 510(k) number K170406.

Who is the listed applicant for Plato MICROCATH 27B Microcatheter?

The FDA 510(k) record lists Scientia Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plato MICROCATH 27B Microcatheter?

The FDA product code for Plato MICROCATH 27B Microcatheter 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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