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FDA 510(k)

NMI MICROCATHETER

K-Number: K121954 · 2012-07-17

ApplicantNavilyst Medical, Inc.
Decision Date2012-07-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NMI MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2012-07-17 under 510(k) number K121954. 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 NMI MICROCATHETER?

NMI MICROCATHETER is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K121954.

When did NMI MICROCATHETER receive FDA 510(k) clearance?

NMI MICROCATHETER received FDA 510(k) clearance on 2012-07-17, under 510(k) number K121954.

Who is the listed applicant for NMI MICROCATHETER?

The FDA 510(k) record lists Navilyst Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NMI MICROCATHETER?

The FDA product code for NMI MICROCATHETER is DQO.

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Other records listing Navilyst Medical, Inc. as applicant

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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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