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FDA 510(k)

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM

K-Number: K950276 · 1995-09-22

ApplicantEndosonics Corp.
Decision Date1995-09-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K950276. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM?

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Endosonics Corp.. The 510(k) number is K950276.

When did MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1995-09-22, under 510(k) number K950276.

Who is the listed applicant for MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM?

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 MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM?

The FDA product code for MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM is IYO.

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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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