FDA 510(k)

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

K-Number: K071234 · 2007-06-29

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2007-06-29

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F 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 2007-06-29 under 510(k) number K071234. 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 DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F?

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K071234.

When did ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F receive FDA 510(k) clearance?

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071234.

Who is the listed applicant for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F?

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 DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F?

The FDA product code for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F is OBJ.

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Official Source

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