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FDA 510(k)

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER

K-Number: K992631 · 1999-12-15

ApplicantAcuson Corp.
Decision Date1999-12-15
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1999-12-15 under 510(k) number K992631. 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 ACUNAV DIAGNOSTIC ULTRASOUND CATHETER?

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is Acuson Corp.. The 510(k) number is K992631.

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

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER received FDA 510(k) clearance on 1999-12-15, under 510(k) number K992631.

Who is the listed applicant for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER?

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

What is the FDA product code for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER?

The FDA product code for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER is DQO.

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Other records listing Acuson Corp. as applicant

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K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMK022896CSV12 SOFTWARE VIEWERK022567SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEMK021497CYPRESS ULTRASOUND SYSTEMK010950CYPRESS SYSTEMK0028073D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

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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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