FDA 510(k)

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700

K-Number: K000820 · 2000-06-05

Decision Date2000-06-05

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K000820. 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 AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700?

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Endosonics Corp.. The 510(k) number is K000820.

When did AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 receive FDA 510(k) clearance?

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 received FDA 510(k) clearance on 2000-06-05, under 510(k) number K000820.

Who is the listed applicant for AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700?

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

What is the FDA product code for AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700?

The FDA product code for AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 is DQO.

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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.