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FDA 510(k)

DIAGNOSTIC INTRAVASCULAR CATHETER

K-Number: K800171 · 1980-02-01

ApplicantFlomed, Inc.
Decision Date1980-02-01
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC INTRAVASCULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Flomed, Inc.. It received FDA 510(k) clearance on 1980-02-01 under 510(k) number K800171. 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 DIAGNOSTIC INTRAVASCULAR CATHETER?

DIAGNOSTIC INTRAVASCULAR CATHETER is a medical device that received FDA 510(k) clearance on 1980-02-01. The listed applicant is Flomed, Inc.. The 510(k) number is K800171.

When did DIAGNOSTIC INTRAVASCULAR CATHETER receive FDA 510(k) clearance?

DIAGNOSTIC INTRAVASCULAR CATHETER received FDA 510(k) clearance on 1980-02-01, under 510(k) number K800171.

Who is the listed applicant for DIAGNOSTIC INTRAVASCULAR CATHETER?

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

What is the FDA product code for DIAGNOSTIC INTRAVASCULAR CATHETER?

The FDA product code for DIAGNOSTIC INTRAVASCULAR CATHETER is DQO.

Related Clinical Trials

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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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