FDA 510(k)

ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER

K-Number: K033650 · 2004-02-24

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2004-02-24

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2004-02-24 under 510(k) number K033650. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER?

ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER is a medical device that received FDA 510(k) clearance on 2004-02-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K033650.

When did ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER receive FDA 510(k) clearance?

ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER received FDA 510(k) clearance on 2004-02-24, under 510(k) number K033650.

Who is the listed applicant for ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER?

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

What is the FDA product code for ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER?

The FDA product code for ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER is OBJ.

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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.